Back to resultsCoformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
Primary Purpose
Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab/Vibostolimab
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Eligibility Criteria
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
- Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
- Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
- Has a life expectancy of at least 3 months
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
- Has adequate organ function
Exclusion Criteria:
- Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
- Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
- Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
- Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
- Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
- Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
- Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
- Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
- Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
- Has a known history of Hepatitis B or known active Hepatitis C virus infection
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Sites / Locations
- Boca Raton Regional Hospital ( Site 0004)Recruiting
- Illinois Cancer Care ( Site 0026)Recruiting
- Mercy Research - David C. Pratt Cancer Center ( Site 0025)Recruiting
- Mercy Research - Cancer and Hematology Center ( Site 0032)Recruiting
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 0013)
- Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)Recruiting
- Hospital São Carlos-Oncocentro Ce ( Site 0208)Recruiting
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)Recruiting
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)Recruiting
- Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em CânRecruiting
- CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)Recruiting
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)Recruiting
- Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)Recruiting
- Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)Recruiting
- BC Cancer Victoria-Clinical Trials Unit ( Site 0107)Recruiting
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)Recruiting
- Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)Recruiting
- Lakeridge Health ( Site 0106)Recruiting
- Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de LavaRecruiting
- James Lind Centro de Investigación del Cáncer ( Site 0711)Recruiting
- CIDO SpA-Oncology ( Site 0707)Recruiting
- IC La Serena Research ( Site 0710)Recruiting
- Clínica Puerto Montt ( Site 0713)Recruiting
- Oncocentro Valdivia ( Site 0715)Recruiting
- Clinica Universidad Catolica del Maule-Oncology ( Site 0703)Recruiting
- FALP ( Site 0702)Recruiting
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)Recruiting
- Orlandi Oncologia ( Site 0700)Recruiting
- Bradfordhill ( Site 0701)Recruiting
- Centro de Investigación Oncológica del Norte ( Site 0708)Recruiting
- The First Affiliated Hospital of Anhui Medical University ( Site 2022)
- Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)
- Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)
- Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)
- Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)
- Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)
- Beijing Chest Hospital,Capital Medical University ( Site 2020)
- Chongqing Cancer Hospital-Medical Oncology ( Site 2028)
- Army Medical Center of People's Liberation Army-respiratory ( Site 2025)
- Fujian Provincial Cancer Hospital-oncology department ( Site 2023)
- Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)
- Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
- Harbin Medical University Cancer Hospital ( Site 2006)
- Henan Cancer Hospital ( Site 2015)
- Wuhan Union Hospital-Medical Oncology ( Site 2019)
- Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)
- Hunan Cancer Hospital-thoracic oncology II ( Site 2013)
- Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)
- Jilin Cancer Hospital-oncology department ( Site 2000)
- Tang Du Hospital ( Site 2004)
- The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)
- LinYi Cancer Hospital ( Site 2034)
- Linyi People's Hospital-Oncology ( Site 2035)
- Fudan University Shanghai Cancer Center ( Site 2032)Recruiting
- West China Hospital Sichuan University-respiratory ( Site 2018)
- Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)Recruiting
- Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)
- The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
- The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( SiteRecruiting
- Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)Recruiting
- The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)
- Instituto de Oncologia ( Site 2300)Recruiting
- CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)Recruiting
- Onco Go, S.A ( Site 0306)Recruiting
- CELAN,S.A ( Site 0304)Recruiting
- Gastrosoluciones ( Site 0302)Recruiting
- INTEGRA Cancer Institute ( Site 0303)Recruiting
- Oncomedica-Guatemala ( Site 0301)Recruiting
- Grupo Medico Angeles-Grupo Medico Angeles ( Site 3007)Recruiting
- Hong Kong Integrated Oncology Centre ( Site 1301)Recruiting
- Queen Mary Hospital ( Site 1303)Recruiting
- Hong Kong United Oncology Centre ( Site 1302)Recruiting
- Princess Margaret Hospital ( Site 1304)Recruiting
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201)Recruiting
- Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207)Recruiting
- Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205)Recruiting
- Mátrai Gyógyintézet ( Site 1214)Recruiting
- Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200)Recruiting
- Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204)Recruiting
- Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)Recruiting
- Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202)Recruiting
- Semmelweis University-Pulmonológiai Klinika ( Site 1209)Recruiting
- National Hospital Organization Nagoya Medical Center ( Site 1920)Recruiting
- Fujita Health University ( Site 1906)Recruiting
- Ehime University Hospital ( Site 1911)Recruiting
- Kurume University Hospital ( Site 1912)Recruiting
- Gunma Prefectural Cancer Center ( Site 1925)Recruiting
- National Hospital Organization Hokkaido Cancer Center ( Site 1923)Recruiting
- Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922)Recruiting
- Takarazuka City Hospital ( Site 1924)Recruiting
- Kanagawa Cardiovascular and Respiratory Center ( Site 1921)Recruiting
- Kanagawa cancer center ( Site 1916)Recruiting
- Sendai Kousei Hospital ( Site 1900)Recruiting
- Niigata Cancer Center Hospital ( Site 1904)Recruiting
- Kansai Medical University Hospital ( Site 1914)Recruiting
- Kindai University Hospital- Osakasayama Campus ( Site 1907)Recruiting
- National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( SitRecruiting
- Osaka Medical and Pharmaceutical University Hospital ( Site 1908)Recruiting
- Shizuoka Cancer Center ( Site 1905)Recruiting
- Tochigi Cancer Center ( Site 1927)Recruiting
- Chiba University Hospital-Medical Oncology ( Site 1926)Recruiting
- Okayama University Hospital ( Site 1913)Recruiting
- Osaka International Cancer Institute ( Site 1915)Recruiting
- Tokushima University Hospital ( Site 1917)Recruiting
- Juntendo University Hospital ( Site 1902)Recruiting
- Japanese Foundation for Cancer Research ( Site 1901)Recruiting
- Wakayama Medical University Hospital ( Site 1910)Recruiting
- Chungbuk National University Hospital-Internal medicine ( Site 1406)Recruiting
- National Cancer Center-Lung Cancer Center ( Site 1407)Recruiting
- Seoul National University Bundang Hospital ( Site 1403)Recruiting
- The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405)Recruiting
- Seoul National University Hospital ( Site 1401)Recruiting
- Kangbuk Samsung Hospital ( Site 1409)Recruiting
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410)Recruiting
- Severance Hospital, Yonsei University Health System ( Site 1402)Recruiting
- Asan Medical Center ( Site 1400)Recruiting
- The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408)Recruiting
- University Malaya Medical Centre ( Site 1504)Recruiting
- Hospital Tengku Ampuan Afzan ( Site 1502)Recruiting
- Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503)Recruiting
- Hospital Pulau Pinang ( Site 1501)Recruiting
- National Cancer Institute ( Site 1505)Recruiting
- Arké SMO S.A. de C.V. ( Site 0417)Recruiting
- Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411)Recruiting
- Centro de Investigacion Clinica Chapultepec ( Site 0400)Recruiting
- iCan Oncology Center Centro Medico AVE ( Site 0405)Recruiting
- Hospital H+ Queretaro ( Site 0416)Recruiting
- Medical Care and Research SA de CV ( Site 0409)Recruiting
- Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402)Recruiting
- Human Science Research Trials ( Site 0406)
- Oaxaca Site Management Organization ( Site 0403)Recruiting
- UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504)Recruiting
- Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508)Recruiting
- Clínica Internacional - Sede San Borja ( Site 0506)Recruiting
- IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507)Recruiting
- INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500)Recruiting
- Hospital Militar Central Luis Arias Schereiber ( Site 0502)Recruiting
- CARDINAL SANTOS MEDICAL CENTER ( Site 1606)Recruiting
- Cardiomed SRL Cluj-Napoca ( Site 2201)Recruiting
- Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202)Recruiting
- SC Medical Center Gral SRL ( Site 2203)Recruiting
- Moscow Regional Oncological Dispensary ( Site 0812)
- Hadassah Medical-Oncology department ( Site 0814)
- Central Clinical Hospital of the Presidential Administrative Department ( Site 0802)
- Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809)
- GBUZ LOKB-Oncology department #1 ( Site 0804)
- Republican Clinical Oncology Dispensary ( Site 0805)
- Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803)
- Wits Clinical Research ( Site 0900)Recruiting
- Medical Oncology Centre of Rosebank ( Site 0906)Recruiting
- LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901)Recruiting
- Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902)Recruiting
- Wits Clinical Research-Wits Clinical Research Bara ( Site 0908)Recruiting
- The Oncology Centre ( Site 0905)Recruiting
- Abraham Oncology ( Site 0907)Recruiting
- Cape Town Oncology Trials ( Site 0903)Recruiting
- Changhua Christian Hospital ( Site 1711)Recruiting
- Chang Gung Memorial Hospital at Kaohsiung ( Site 1702)Recruiting
- Tri-Service General Hospital-hematology&oncology ( Site 1710)Recruiting
- National Taiwan University Hospital - Hsinchu branch ( Site 1704)Recruiting
- Taichung Veterans General Hospital-Chest ( Site 1707)Recruiting
- NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1705)Recruiting
- National Taiwan University Hospital-Oncology ( Site 1706)Recruiting
- Mackay Memorial Hospital-Chest Medicine ( Site 1703)Recruiting
- Taipei Medical University Hospital ( Site 1712)Recruiting
- Taipei Veterans General Hospital ( Site 1709)Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 1708)Recruiting
- Chulalongkorn University ( Site 1802)Recruiting
- Ramathibodi Clinical Research Centre ( Site 1801)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 1800)Recruiting
- Erciyes University Medical Oncology Department ( Site 1007)Recruiting
- Hacettepe Universitesi-oncology hospital ( Site 1001)
- Memorial Ankara Hastanesi-Medical Oncology ( Site 1002)Recruiting
- Gazi Universitesi-Oncology ( Site 1003)Recruiting
- Acıbadem Maslak Hastanesi ( Site 1008)Recruiting
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000)Recruiting
- Samsun Medical Park Hastanesi-medical oncology ( Site 1005)
- Cherkasy Regional Oncology Dispensary ( Site 1110)
- Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113)
- Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100)
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104)
- Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio
- Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119)
- National Cancer Institute ( Site 1114)
- Vinnytsia Regional Clinical Oncological Hospital ( Site 1102)
- Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120)
- Oncolife LLC-day-stay department ( Site 1107)
- Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab/Vibostolimab
Pembrolizumab
Arm Description
Participants will receive pembrolizumab/vibostolimab as a coformulation (MK-7684A).
Participants will receive pembrolizumab (MK-3475) alone.
Outcomes
Primary Outcome Measures
Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
OS is defined as the time from randomization to death due to any cause.
OS in Participants With PD-L1 TPS ≥1%
OS is defined as the time from randomization to death due to any cause.
OS in Participants With PD-L1 TPS 1% to 49%
OS is defined as the time from randomization to death due to any cause.
Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
PFS in Participants With PD-L1 TPS ≥50%
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
Secondary Outcome Measures
Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
PFS in Participants With PD-L1 TPS 1% to 49%
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
ORR in Participants With PD-L1 TPS ≥50%
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
ORR in Participants With PD-L1 TPS 1% to 49%
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
DOR in Participants With PD-L1 TPS 1% to 49%
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
DOR in Participants With PD-L1 TPS ≥1%
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50%
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) in Participants With PD-L1 TPS ≥50%
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49%
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Number of Participants Who Experienced One or More Adverse Events (AEs)
The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Full Information
NCT ID
NCT04738487
First Posted
February 2, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04738487
Brief Title
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
April 21, 2026 (Anticipated)
Study Completion Date
June 5, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), in participants with PD-L1 TPS ≥1% and TPS ≥50%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab/Vibostolimab
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab/vibostolimab as a coformulation (MK-7684A).
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants will receive pembrolizumab (MK-3475) alone.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Vibostolimab
Other Intervention Name(s)
MK-7684A
Intervention Description
Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda
Intervention Description
Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years).
Primary Outcome Measure Information:
Title
Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~59 months
Title
OS in Participants With PD-L1 TPS ≥1%
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~59 months
Title
OS in Participants With PD-L1 TPS 1% to 49%
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~59 months
Title
Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
Time Frame
Up to ~51 months
Title
PFS in Participants With PD-L1 TPS ≥50%
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
Time Frame
Up to ~51 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%
Description
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Time Frame
Up to ~ 2 years
Title
PFS in Participants With PD-L1 TPS 1% to 49%
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
Time Frame
Up to ~51 months
Title
ORR in Participants With PD-L1 TPS ≥50%
Description
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Time Frame
Up to ~ 2 years
Title
ORR in Participants With PD-L1 TPS 1% to 49%
Description
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Time Frame
Up to ~ 2 years
Title
Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%
Description
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
Time Frame
Up to ~59 months
Title
DOR in Participants With PD-L1 TPS 1% to 49%
Description
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
Time Frame
Up to ~59 months
Title
DOR in Participants With PD-L1 TPS ≥1%
Description
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
Time Frame
Up to ~59 months
Title
Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) in Participants With PD-L1 TPS ≥50%
Description
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Description
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Description
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Description
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Description
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time Frame
Baseline and up to ~107 weeks
Title
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Description
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time Frame
Baseline and up to ~107 weeks
Title
Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49%
Description
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Description
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Description
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Description
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Description
TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Description
TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Description
TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Description
TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Description
TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Description
TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Baseline and up to ~107 weeks
Title
Number of Participants Who Experienced One or More Adverse Events (AEs)
Description
The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Time Frame
Up to ~115 weeks
Title
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Description
The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Time Frame
Up to ~103 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
Has a life expectancy of at least 3 months
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP)
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
Has adequate organ function
Exclusion Criteria:
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Boca Raton Regional Hospital ( Site 0004)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
561-955-4862
Facility Name
Illinois Cancer Care ( Site 0026)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
309-243-3000
Facility Name
Mercy Research - David C. Pratt Cancer Center ( Site 0025)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-251-7057
Facility Name
Mercy Research - Cancer and Hematology Center ( Site 0032)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
417-820-8099
Facility Name
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
516-351-5757
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0013)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-728-2451
Facility Name
Hospital São Carlos-Oncocentro Ce ( Site 0208)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+55 853034-8677
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
558440095595
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+555531950504
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
555132148143
Facility Name
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88020-210
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
554833311553
Facility Name
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+55 11 3893-3530
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
551134744278
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+55 21 3207-6569
Facility Name
BC Cancer Victoria-Clinical Trials Unit ( Site 0107)
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
2505195572
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9053879495
Facility Name
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6135496666
Facility Name
Lakeridge Health ( Site 0106)
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9055768711
Facility Name
Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
450-668-1010 x23603
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 0711)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56452982404
Facility Name
CIDO SpA-Oncology ( Site 0707)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810148
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
569 5 798 31 73
Facility Name
IC La Serena Research ( Site 0710)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56512386127
Facility Name
Clínica Puerto Montt ( Site 0713)
City
Puerto Montt
State/Province
Los Lagos
ZIP/Postal Code
5500243
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56998634501
Facility Name
Oncocentro Valdivia ( Site 0715)
City
Valdivia
State/Province
Los Rios
ZIP/Postal Code
5112129
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56232634933
Facility Name
Clinica Universidad Catolica del Maule-Oncology ( Site 0703)
City
Talca
State/Province
Maule
ZIP/Postal Code
3465584
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56712635600
Facility Name
FALP ( Site 0702)
City
Providencia
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56227067543
Facility Name
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56991612199
Facility Name
Orlandi Oncologia ( Site 0700)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500713
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56992214787
Facility Name
Bradfordhill ( Site 0701)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56229490970
Facility Name
Centro de Investigación Oncológica del Norte ( Site 0708)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56552654147
Facility Name
The First Affiliated Hospital of Anhui Medical University ( Site 2022)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230036
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Chest Hospital,Capital Medical University ( Site 2020)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Completed
Facility Name
Chongqing Cancer Hospital-Medical Oncology ( Site 2028)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Army Medical Center of People's Liberation Army-respiratory ( Site 2025)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fujian Provincial Cancer Hospital-oncology department ( Site 2023)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Harbin Medical University Cancer Hospital ( Site 2006)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Henan Cancer Hospital ( Site 2015)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wuhan Union Hospital-Medical Oncology ( Site 2019)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Cancer Hospital-thoracic oncology II ( Site 2013)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jilin Cancer Hospital-oncology department ( Site 2000)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tang Du Hospital ( Site 2004)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
LinYi Cancer Hospital ( Site 2034)
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Linyi People's Hospital-Oncology ( Site 2035)
City
Linyi
State/Province
Shandong
Country
China
Individual Site Status
Completed
Facility Name
Fudan University Shanghai Cancer Center ( Site 2032)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 02164175590
Facility Name
West China Hospital Sichuan University-respiratory ( Site 2018)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8618857110928
Facility Name
Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13958194313
Facility Name
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13867622009
Facility Name
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
32500
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Oncologia ( Site 2300)
City
Santo Domingo
State/Province
Distrito Nacional
ZIP/Postal Code
10102
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8099650355
Facility Name
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)
City
Santo Domingo
State/Province
Distrito Nacional
ZIP/Postal Code
10104
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(829) 341-7774
Facility Name
Onco Go, S.A ( Site 0306)
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259042511
Facility Name
CELAN,S.A ( Site 0304)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50242142081
Facility Name
Gastrosoluciones ( Site 0302)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50245711895
Facility Name
INTEGRA Cancer Institute ( Site 0303)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+502 54530410
Facility Name
Oncomedica-Guatemala ( Site 0301)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50256973689
Facility Name
Grupo Medico Angeles-Grupo Medico Angeles ( Site 3007)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50257042323
Facility Name
Hong Kong Integrated Oncology Centre ( Site 1301)
City
Central
ZIP/Postal Code
0000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85237006888
Facility Name
Queen Mary Hospital ( Site 1303)
City
Hksar
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85222554361
Facility Name
Hong Kong United Oncology Centre ( Site 1302)
City
Jordan
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85223868002
Facility Name
Princess Margaret Hospital ( Site 1304)
City
Lai Chi Kok
ZIP/Postal Code
999007
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85229902393
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3676519853
Facility Name
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207)
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36665265262528
Facility Name
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3696507900
Facility Name
Mátrai Gyógyintézet ( Site 1214)
City
Kékestető
State/Province
Heves
ZIP/Postal Code
3233
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
203929250
Facility Name
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3656503603
Facility Name
Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204)
City
Budapest
State/Province
Pest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3613913351
Facility Name
Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)
City
Törökbálint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36307005601
Facility Name
Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202)
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3692501527
Facility Name
Semmelweis University-Pulmonológiai Klinika ( Site 1209)
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3614591500
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 1920)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-951-1111
Facility Name
Fujita Health University ( Site 1906)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-562-93-2111
Facility Name
Ehime University Hospital ( Site 1911)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-89-964-5111
Facility Name
Kurume University Hospital ( Site 1912)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-942-35-3311
Facility Name
Gunma Prefectural Cancer Center ( Site 1925)
City
Otashi
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-276-38-0771
Facility Name
National Hospital Organization Hokkaido Cancer Center ( Site 1923)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-11-811-9111
Facility Name
Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922)
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
6638501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-798-45-6111
Facility Name
Takarazuka City Hospital ( Site 1924)
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-797-87-1161
Facility Name
Kanagawa Cardiovascular and Respiratory Center ( Site 1921)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-45-701-9581
Facility Name
Kanagawa cancer center ( Site 1916)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-45-520-2222
Facility Name
Sendai Kousei Hospital ( Site 1900)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9800873
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-222-6181
Facility Name
Niigata Cancer Center Hospital ( Site 1904)
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-25-266-5111
Facility Name
Kansai Medical University Hospital ( Site 1914)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
5731191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-804-0101
Facility Name
Kindai University Hospital- Osakasayama Campus ( Site 1907)
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-366-0221
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-252-3021
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 1908)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-683-1221
Facility Name
Shizuoka Cancer Center ( Site 1905)
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-55-989-5222
Facility Name
Tochigi Cancer Center ( Site 1927)
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-28-658-5151
Facility Name
Chiba University Hospital-Medical Oncology ( Site 1926)
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-43-222-7171
Facility Name
Okayama University Hospital ( Site 1913)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-86-223-7151
Facility Name
Osaka International Cancer Institute ( Site 1915)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81669451181
Facility Name
Tokushima University Hospital ( Site 1917)
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-88-631-3111
Facility Name
Juntendo University Hospital ( Site 1902)
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3813-3111
Facility Name
Japanese Foundation for Cancer Research ( Site 1901)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3520-0111
Facility Name
Wakayama Medical University Hospital ( Site 1910)
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-73-447-2300
Facility Name
Chungbuk National University Hospital-Internal medicine ( Site 1406)
City
Cheongju-si
State/Province
Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-42-269-8760
Facility Name
National Cancer Center-Lung Cancer Center ( Site 1407)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82319201694
Facility Name
Seoul National University Bundang Hospital ( Site 1403)
City
Seongnam
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-31-1588-3369
Facility Name
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-31-1577-8588
Facility Name
Seoul National University Hospital ( Site 1401)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-2072-2995
Facility Name
Kangbuk Samsung Hospital ( Site 1409)
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220011130
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-2-2030-4360
Facility Name
Severance Hospital, Yonsei University Health System ( Site 1402)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-1599-1004
Facility Name
Asan Medical Center ( Site 1400)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-2-3010-3214
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8215881511
Facility Name
University Malaya Medical Centre ( Site 1504)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60378414000
Facility Name
Hospital Tengku Ampuan Afzan ( Site 1502)
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6095572923
Facility Name
Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503)
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10050
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6042225685
Facility Name
Hospital Pulau Pinang ( Site 1501)
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6042225768
Facility Name
National Cancer Institute ( Site 1505)
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
60388925555
Facility Name
Arké SMO S.A. de C.V. ( Site 0417)
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33 38 08 08 56
Facility Name
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+523316395372
Facility Name
Centro de Investigacion Clinica Chapultepec ( Site 0400)
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58260
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+524431478545
Facility Name
iCan Oncology Center Centro Medico AVE ( Site 0405)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+528125558169
Facility Name
Hospital H+ Queretaro ( Site 0416)
City
Santiago de Queretaro
State/Province
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
524421145730
Facility Name
Medical Care and Research SA de CV ( Site 0409)
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+529999203879
Facility Name
Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402)
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+526141803800
Facility Name
Human Science Research Trials ( Site 0406)
City
Mexico city
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Oaxaca Site Management Organization ( Site 0403)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+529515147056
Facility Name
UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504)
City
Cusco
State/Province
Qusqu
ZIP/Postal Code
CUSCO 84
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51987531715
Facility Name
Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508)
City
Lima
ZIP/Postal Code
15001
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51999903343
Facility Name
Clínica Internacional - Sede San Borja ( Site 0506)
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51992004083
Facility Name
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507)
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51 997881134
Facility Name
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500)
City
Lima
ZIP/Postal Code
15038
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51993473019
Facility Name
Hospital Militar Central Luis Arias Schereiber ( Site 0502)
City
Lima
ZIP/Postal Code
15076
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
51997468543
Facility Name
CARDINAL SANTOS MEDICAL CENTER ( Site 1606)
City
San Juan City, Metro Manila
State/Province
National Capital Region
ZIP/Postal Code
1502
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
639176227242
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 2201)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040724543672
Facility Name
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722161545
Facility Name
SC Medical Center Gral SRL ( Site 2203)
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100010
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040740062630
Facility Name
Moscow Regional Oncological Dispensary ( Site 0812)
City
Balashikha
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143900
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hadassah Medical-Oncology department ( Site 0814)
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
121205
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Central Clinical Hospital of the Presidential Administrative Department ( Site 0802)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809)
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603081
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
GBUZ LOKB-Oncology department #1 ( Site 0804)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194291
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Republican Clinical Oncology Dispensary ( Site 0805)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803)
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Wits Clinical Research ( Site 0900)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27113390600
Facility Name
Medical Oncology Centre of Rosebank ( Site 0906)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0824445473
Facility Name
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27826061150
Facility Name
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902)
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27118830900
Facility Name
Wits Clinical Research-Wits Clinical Research Bara ( Site 0908)
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0834077151
Facility Name
The Oncology Centre ( Site 0905)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27312088666
Facility Name
Abraham Oncology ( Site 0907)
City
Richards Bay
State/Province
Kwazulu-Natal
ZIP/Postal Code
3900
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0845493493
Facility Name
Cape Town Oncology Trials ( Site 0903)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27219443832
Facility Name
Changhua Christian Hospital ( Site 1711)
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-4-7238595
Facility Name
Chang Gung Memorial Hospital at Kaohsiung ( Site 1702)
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88677317123
Facility Name
Tri-Service General Hospital-hematology&oncology ( Site 1710)
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-2-87927208
Facility Name
National Taiwan University Hospital - Hsinchu branch ( Site 1704)
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886353261514529
Facility Name
Taichung Veterans General Hospital-Chest ( Site 1707)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-4-23592525 ext.3219
Facility Name
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1705)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886623535354559
Facility Name
National Taiwan University Hospital-Oncology ( Site 1706)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88622312345667511
Facility Name
Mackay Memorial Hospital-Chest Medicine ( Site 1703)
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-25433535
Facility Name
Taipei Medical University Hospital ( Site 1712)
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-2-27372181
Facility Name
Taipei Veterans General Hospital ( Site 1709)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-2-28757865
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 1708)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886-3-3281200 ext.2285
Facility Name
Chulalongkorn University ( Site 1802)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+662-256-4533
Facility Name
Ramathibodi Clinical Research Centre ( Site 1801)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6622011671
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 1800)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6624194489
Facility Name
Erciyes University Medical Oncology Department ( Site 1007)
City
Talas
State/Province
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903524374912
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 1001)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Memorial Ankara Hastanesi-Medical Oncology ( Site 1002)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903122536666
Facility Name
Gazi Universitesi-Oncology ( Site 1003)
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903122025825
Facility Name
Acıbadem Maslak Hastanesi ( Site 1008)
City
İstanbul
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905062979770
Facility Name
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000)
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324167355
Facility Name
Samsun Medical Park Hastanesi-medical oncology ( Site 1005)
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Cherkasy Regional Oncology Dispensary ( Site 1110)
City
Cherkassy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113)
City
Chernihiv
State/Province
Chernihivska Oblast
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Suspended
Facility Name
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104)
City
Kryvyi Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61103
Country
Ukraine
Individual Site Status
Suspended
Facility Name
National Cancer Institute ( Site 1114)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Vinnytsia Regional Clinical Oncological Hospital ( Site 1102)
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21029
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120)
City
Uzhhorod
State/Province
Zakarpatska Oblast
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Oncolife LLC-day-stay department ( Site 1107)
City
Zaporizhzhia
State/Province
Zaporizka Oblast
ZIP/Postal Code
69059
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103)
City
Zhytomyr
State/Province
Zhytomyrska Oblast
ZIP/Postal Code
10002
Country
Ukraine
Individual Site Status
Suspended
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
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