Back to resultsStudy of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pembrolizumab/vibostolimab
durvalumab
cisplatin
pemetrexed
etoposide
carboplatin
paclitaxel
thoracic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
- Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
- Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
- Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
- Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
- Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
- Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
- Has a life expectancy of at least 6 months
Exclusion Criteria
- Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
- Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
- Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
- Is expected to require any other form of antineoplastic therapy, while on study
- Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- 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 medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
- Has had an allogenic tissue/solid organ transplant
Pemetrexed-specific Criteria:
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
- Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Sites / Locations
- VA Long Beach Healthcare System ( Site 2831)Recruiting
- VA West Los Angeles Medical Center ( Site 2808)Recruiting
- Millennium Oncology Research Clinic ( Site 2801)Recruiting
- Mid Florida Hematology and Oncology Center ( Site 2800)Recruiting
- MFSMC-HJWCI ( Site 2804)Recruiting
- Boston Medical Center ( Site 2829)Recruiting
- University of Massachusetts Chan Medical School ( Site 2815)Recruiting
- Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)Recruiting
- Rutgers Cancer Institute of New Jersey ( Site 2805)Recruiting
- White Plains Hospital ( Site 2835)Recruiting
- Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)Recruiting
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)Recruiting
- Thomas Jefferson University - Clinical Research Institute ( Site 2813)Recruiting
- Millennium Research & Clinical Development ( Site 2811)Recruiting
- Central Texas Veterans health care-Oncology & Hematology ( Site 2819)Recruiting
- MultiCare Health System ( Site 2817)Recruiting
- Canberra Hospital ( Site 0010)Recruiting
- Icon Cancer Centre Hobart ( Site 0003)Recruiting
- Ballarat Health Services-Medical Oncology ( Site 0002)Recruiting
- Frankston Hospital-Oncology and Haematology ( Site 0009)Recruiting
- St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)Recruiting
- Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)Recruiting
- A. C. Camargo Cancer Center-CAPEC ( Site 0102)Recruiting
- James Lind Centro de Investigación del Cáncer ( Site 0202)Recruiting
- Biocenter ( Site 0208)
- FALP-UIDO ( Site 0205)Recruiting
- Centro de Oncología de Precisión ( Site 0209)Recruiting
- Bradfordhill ( Site 0200)Recruiting
- ONCOCENTRO APYS-ACEREY ( Site 0203)Recruiting
- Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)Recruiting
- Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)Recruiting
- Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)Recruiting
- Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)Recruiting
- Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)Recruiting
- Fujian Provincial Cancer Hospital ( Site 0316)Recruiting
- The First Affiliated hospital of Xiamen University-oncology ( Site 0317)Recruiting
- Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)Recruiting
- Fourth Hospital of Hebei Medical University ( Site 0331)Recruiting
- Henan Cancer Hospital ( Site 0333)Recruiting
- Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315)Recruiting
- Hubei Cancer Hospital ( Site 0311)Recruiting
- Xiangya Hospital Central South University-Oncology department ( Site 0310)Recruiting
- Hunan Cancer Hospital ( Site 0307)Recruiting
- The Second Affiliated Hospital of Soochow University ( Site 0314)Recruiting
- Affiliated Hospital of Jiangsu University ( Site 0305)Recruiting
- Jilin Cancer Hospital-oncology department ( Site 0319)Recruiting
- Shandong Provincial Hospital ( Site 0326)Recruiting
- Qingdao Central Hospital-Endocrinology ( Site 0332)Recruiting
- Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)Recruiting
- Fudan University Shanghai Cancer Center ( Site 0304)Recruiting
- Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)Recruiting
- Shanxi Cancer Hospital-Pulmonology ( Site 0322)Recruiting
- West China Hospital of Sichuan University ( Site 0324)Recruiting
- Tianjin Medical University Cancer Institute and Hospital-radiotherapy ( Site 0329)Recruiting
- Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)Recruiting
- The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)Recruiting
- Zhejiang Cancer Hospital ( Site 0308)Recruiting
- CIMCA ( Site 0501)Recruiting
- PROCLINICAL Pharma ( Site 0504)Recruiting
- Hospital Metropolitano - Sede Lindora ( Site 0503)Recruiting
- Instituto de Oncologia ( Site 3003)Recruiting
- Onconet ( Site 3002)Recruiting
- Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)Recruiting
- LungenClinic Grosshansdorf-Onkologie ( Site 0602)Recruiting
- Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und OnkoloRecruiting
- Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)Recruiting
- Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)Recruiting
- Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)Recruiting
- Metropolitan Hospital ( Site 0702)Recruiting
- General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 07Recruiting
- University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)Recruiting
- European Interbalkan Medical Center ( Site 0701)Recruiting
- Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)Recruiting
- Centro Regional de Sub Especialidades Médicas SA ( Site 0801)Recruiting
- Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)Recruiting
- Rambam Health Care Campus-Oncology ( Site 1001)Recruiting
- Shaare Zedek Medical Center ( Site 1003)Recruiting
- Rabin Medical Center ( Site 1004)Recruiting
- Sheba Medical Center-ONCOLOGY ( Site 1000)Recruiting
- Sourasky Medical Center ( Site 1002)Recruiting
- Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)Recruiting
- Ospedale San Raffaele ( Site 1104)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)Recruiting
- Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)Recruiting
- Fondazione IRCCS Policlinico San Matteo ( Site 1103)Recruiting
- National Hospital Organization Shikoku Cancer Center ( Site 1211)Recruiting
- Kurume University Hospital ( Site 1212)Recruiting
- Kobe Minimally Invasive Cancer Center ( Site 1210)Recruiting
- Kanagawa cancer center ( Site 1204)Recruiting
- Miyagi Cancer Center ( Site 1200)Recruiting
- Sendai Kousei Hospital ( Site 1213)Recruiting
- Niigata Cancer Center Hospital ( Site 1205)Recruiting
- Kansai Medical University Hospital ( Site 1207)Recruiting
- Osaka Medical and Pharmaceutical University Hospital ( Site 1208)Recruiting
- Saitama Prefectural Cancer Center ( Site 1201)Recruiting
- Japanese Foundation for Cancer Research ( Site 1202)Recruiting
- Showa University Hospital ( Site 1203)Recruiting
- Osaka International Cancer Institute ( Site 1209)Recruiting
- Chungbuk National University Hospital-Internal medicine ( Site 2400)Recruiting
- The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)Recruiting
- Ajou University Hospital-Hematology-Oncology ( Site 2402)Recruiting
- Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)Recruiting
- University Malaya Medical Centre-Clinical Oncology ( Site 1402)Recruiting
- Hospital Pulau Pinang ( Site 1400)Recruiting
- Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)Recruiting
- Arké SMO S.A. de C.V. ( Site 1504)Recruiting
- Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)Recruiting
- Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)Recruiting
- Centro de Investigacion Clinica de Oaxaca ( Site 1501)Recruiting
- Hospital CUF Descobertas ( Site 2006)Recruiting
- Centro Hospitalar do Porto - Hospital de Santo António ( Site 2004)Recruiting
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)Recruiting
- Centrul Medical Medicover Victoria ( Site 2106)Recruiting
- Amethyst Radiotherapy Center ( Site 2102)Recruiting
- Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)Recruiting
- Cabinet Medical Oncomed ( Site 2101)Recruiting
- CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)Recruiting
- Wilgers Oncology Centre ( Site 2301)Recruiting
- Abraham Oncology ( Site 2303)Recruiting
- Cape Town Oncology Trials ( Site 2306)Recruiting
- HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( SitRecruiting
- CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)Recruiting
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)Recruiting
- Hospital Universitari Vall d'Hebron ( Site 2501)Recruiting
- Medipol Mega Universite Hastanesi-oncology ( Site 2611)Recruiting
- Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)Recruiting
- I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)Recruiting
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)Recruiting
- Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)Recruiting
- Hacettepe Universitesi-oncology hospital ( Site 2605)Recruiting
- Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)Recruiting
- Ankara City Hospital-Medical Oncology ( Site 2601)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
chemotherapy+radiotherapy+durvalumab
Arm Description
For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) For All Participants
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Overall Survival (OS) For All Participants
OS is defined as the time from randomization to death due to any cause.
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
OS is defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
Objective Response Rate (ORR) For All Participants
ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Duration of Response (DOR) For All Participants
Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Full Information
NCT ID
NCT05298423
First Posted
March 17, 2022
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05298423
Brief Title
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
Official Title
Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
September 1, 2028 (Anticipated)
Study Completion Date
September 4, 2029 (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
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following:
progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants.
overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
784 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
Arm Type
Experimental
Arm Description
For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Arm Title
chemotherapy+radiotherapy+durvalumab
Arm Type
Active Comparator
Arm Description
For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.
Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Intervention Type
Biological
Intervention Name(s)
pembrolizumab/vibostolimab
Other Intervention Name(s)
MK-7684A
Intervention Description
Administered as an intravenous (IV) infusion
Intervention Type
Biological
Intervention Name(s)
durvalumab
Other Intervention Name(s)
IMFINZI®
Intervention Description
Administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
PLATINOL-AQ®
Intervention Description
Administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
ALIMTA®
Intervention Description
Administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
TOPOSAR®
Intervention Description
Administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
Administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
Administered as an IV infusion
Intervention Type
Radiation
Intervention Name(s)
thoracic radiotherapy
Intervention Description
Administered as an external beam radiation
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) For All Participants
Description
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 55 months
Title
Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Description
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 55 months
Title
Overall Survival (OS) For All Participants
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 75 months
Title
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 75 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) For All Participants
Description
ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 75 months
Title
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Description
ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 75 months
Title
Number of Participants Who Experience at Least One Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 75 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 75 months
Title
Duration of Response (DOR) For All Participants
Description
Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 75 months
Title
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Description
Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 75 months
Title
Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Description
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Description
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Time Frame
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Title
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Description
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
Title
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Description
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time Frame
Up to approximately 75 months post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
Has a life expectancy of at least 6 months
Exclusion Criteria
Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
Is expected to require any other form of antineoplastic therapy, while on study
Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
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 medication
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
Has had an allogenic tissue/solid organ transplant
Pemetrexed-specific Criteria:
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
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
VA Long Beach Healthcare System ( Site 2831)
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
562-826-8000
Facility Name
VA West Los Angeles Medical Center ( Site 2808)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-478-3711
Facility Name
Millennium Oncology Research Clinic ( Site 2801)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-450-1808
Facility Name
Mid Florida Hematology and Oncology Center ( Site 2800)
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
386-774-1223
Facility Name
MFSMC-HJWCI ( Site 2804)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
443-777-7147
Facility Name
Boston Medical Center ( Site 2829)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-638-8265
Facility Name
University of Massachusetts Chan Medical School ( Site 2815)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
508-334-1000
Facility Name
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
417-269-6115
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 2805)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
732-235-2465
Facility Name
White Plains Hospital ( Site 2835)
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
914-849-7630
Facility Name
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-335-2400
Facility Name
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
717-544-9400
Facility Name
Thomas Jefferson University - Clinical Research Institute ( Site 2813)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-955-8874
Facility Name
Millennium Research & Clinical Development ( Site 2811)
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
281-440-5006
Facility Name
Central Texas Veterans health care-Oncology & Hematology ( Site 2819)
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
254-743-0204
Facility Name
MultiCare Health System ( Site 2817)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
253-403-6177
Facility Name
Canberra Hospital ( Site 0010)
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
610251242220
Facility Name
Icon Cancer Centre Hobart ( Site 0003)
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0437636224
Facility Name
Ballarat Health Services-Medical Oncology ( Site 0002)
City
Ballarat Central
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0413578465
Facility Name
Frankston Hospital-Oncology and Haematology ( Site 0009)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(03) 9784 7071
Facility Name
St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61392313167
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+55212399-0212
Facility Name
A. C. Camargo Cancer Center-CAPEC ( Site 0102)
City
Sao Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+551121895021
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 0202)
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
Biocenter ( Site 0208)
City
Concepción
State/Province
Biobio
ZIP/Postal Code
4070196
Country
Chile
Individual Site Status
Completed
Facility Name
FALP-UIDO ( Site 0205)
City
Santiago
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
+56981369487
Facility Name
Centro de Oncología de Precisión ( Site 0209)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7560908
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56991612199
Facility Name
Bradfordhill ( Site 0200)
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
+56998744662
Facility Name
ONCOCENTRO APYS-ACEREY ( Site 0203)
City
Viña del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56322323980
Facility Name
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
010-88196479
Facility Name
Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
010-88196948
Facility Name
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13911235467
Facility Name
Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18580408265
Facility Name
Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)
City
Fuzhou Fujian
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 0591 86218325
Facility Name
Fujian Provincial Cancer Hospital ( Site 0316)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 0591-62752500
Facility Name
The First Affiliated hospital of Xiamen University-oncology ( Site 0317)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 0592-2132222
Facility Name
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-62787730
Facility Name
Fourth Hospital of Hebei Medical University ( Site 0331)
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13931182128
Facility Name
Henan Cancer Hospital ( Site 0333)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13607695140
Facility Name
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 027-85726300
Facility Name
Hubei Cancer Hospital ( Site 0311)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 027-87670318
Facility Name
Xiangya Hospital Central South University-Oncology department ( Site 0310)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13875898127
Facility Name
Hunan Cancer Hospital ( Site 0307)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0731-89762231
Facility Name
The Second Affiliated Hospital of Soochow University ( Site 0314)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13951106391
Facility Name
Affiliated Hospital of Jiangsu University ( Site 0305)
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613952850016
Facility Name
Jilin Cancer Hospital-oncology department ( Site 0319)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0431-80596065
Facility Name
Shandong Provincial Hospital ( Site 0326)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
15168888787
Facility Name
Qingdao Central Hospital-Endocrinology ( Site 0332)
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86-18660229210
Facility Name
Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13651635103
Facility Name
Fudan University Shanghai Cancer Center ( Site 0304)
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
021-64175590
Facility Name
Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13817025327
Facility Name
Shanxi Cancer Hospital-Pulmonology ( Site 0322)
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18635169066
Facility Name
West China Hospital of Sichuan University ( Site 0324)
City
Cheng Du
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18980601766
Facility Name
Tianjin Medical University Cancer Institute and Hospital-radiotherapy ( Site 0329)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022-23524155
Facility Name
Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)
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
18857110928
Facility Name
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13868071869
Facility Name
Zhejiang Cancer Hospital ( Site 0308)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13858037993
Facility Name
CIMCA ( Site 0501)
City
San José
State/Province
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50683893636
Facility Name
PROCLINICAL Pharma ( Site 0504)
City
San José
State/Province
San Jose
ZIP/Postal Code
11303
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50683778387
Facility Name
Hospital Metropolitano - Sede Lindora ( Site 0503)
City
Santa Ana
State/Province
San Jose
ZIP/Postal Code
10903
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5064035 1212
Facility Name
Instituto de Oncologia ( Site 3003)
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
+18099615245
Facility Name
Onconet ( Site 3002)
City
Distrito Nacional
State/Province
Santo Domingo
ZIP/Postal Code
10148
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+18098611000
Facility Name
Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4937133343072
Facility Name
LungenClinic Grosshansdorf-Onkologie ( Site 0602)
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4941026012101
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4943150022563
Facility Name
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 26
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00302106972246
Facility Name
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00306946462998
Facility Name
Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302107700220
Facility Name
Metropolitan Hospital ( Site 0702)
City
Athens
State/Province
Attiki
ZIP/Postal Code
185 47
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00302104809339
Facility Name
General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 07
City
Nea Kifissia
State/Province
Attiki
ZIP/Postal Code
136 77
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00302103501711
Facility Name
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)
City
Heraklion
State/Province
Irakleio
ZIP/Postal Code
715 00
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00302810392783
Facility Name
European Interbalkan Medical Center ( Site 0701)
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00302310400368
Facility Name
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)
City
Ciudad de Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+502 30635474
Facility Name
Centro Regional de Sub Especialidades Médicas SA ( Site 0801)
City
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+502 59450559
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+502 59458053
Facility Name
Rambam Health Care Campus-Oncology ( Site 1001)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972-4-7776412
Facility Name
Shaare Zedek Medical Center ( Site 1003)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972587040620
Facility Name
Rabin Medical Center ( Site 1004)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+ 9729378101
Facility Name
Sheba Medical Center-ONCOLOGY ( Site 1000)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97235307096
Facility Name
Sourasky Medical Center ( Site 1002)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972 36973494
Facility Name
Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3906225418020
Facility Name
Ospedale San Raffaele ( Site 1104)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390226436627
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390223905000
Facility Name
Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390392339678
Facility Name
Fondazione IRCCS Policlinico San Matteo ( Site 1103)
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390382503132
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 1211)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-89-999-1111
Facility Name
Kurume University Hospital ( Site 1212)
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
Kobe Minimally Invasive Cancer Center ( Site 1210)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-78-304-4100
Facility Name
Kanagawa cancer center ( Site 1204)
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
Miyagi Cancer Center ( Site 1200)
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-384-3151
Facility Name
Sendai Kousei Hospital ( Site 1213)
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 1205)
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 1207)
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
Osaka Medical and Pharmaceutical University Hospital ( Site 1208)
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
Saitama Prefectural Cancer Center ( Site 1201)
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-48-722-1111
Facility Name
Japanese Foundation for Cancer Research ( Site 1202)
City
Koto
State/Province
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
Showa University Hospital ( Site 1203)
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3784-8000
Facility Name
Osaka International Cancer Institute ( Site 1209)
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
+81-6-6945-1181
Facility Name
Chungbuk National University Hospital-Internal medicine ( Site 2400)
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
82432696898
Facility Name
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)
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
82312498485
Facility Name
Ajou University Hospital-Hematology-Oncology ( Site 2402)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
820312194266
Facility Name
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)
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
820222280880
Facility Name
University Malaya Medical Centre-Clinical Oncology ( Site 1402)
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
+6013-5121839
Facility Name
Hospital Pulau Pinang ( Site 1400)
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
+604-2225767
Facility Name
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6017233-6295
Facility Name
Arké SMO S.A. de C.V. ( Site 1504)
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
55 55115833
Facility Name
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)
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
+52 (33) 1639-5372
Facility Name
Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+52 (614) 180-3800
Facility Name
Centro de Investigacion Clinica de Oaxaca ( Site 1501)
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9516035559
Facility Name
Hospital CUF Descobertas ( Site 2006)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351210025200
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António ( Site 2004)
City
Porto
ZIP/Postal Code
4050-366
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351222077500
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225084000
Facility Name
Centrul Medical Medicover Victoria ( Site 2106)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
010626
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40737877881
Facility Name
Amethyst Radiotherapy Center ( Site 2102)
City
Florești
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40742206212
Facility Name
Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722161545
Facility Name
Cabinet Medical Oncomed ( Site 2101)
City
Timișoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040745100495
Facility Name
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6055
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27413630581
Facility Name
Wilgers Oncology Centre ( Site 2301)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0040
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27128072744
Facility Name
Abraham Oncology ( Site 2303)
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
0357800247
Facility Name
Cape Town Oncology Trials ( Site 2306)
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
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932275402
Facility Name
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
981950511
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0034914521987
Facility Name
Hospital Universitari Vall d'Hebron ( Site 2501)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932746085
Facility Name
Medipol Mega Universite Hastanesi-oncology ( Site 2611)
City
Stanbul
State/Province
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325280486
Facility Name
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902323434343
Facility Name
I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)
City
Izmir, Karsiyaka
State/Province
Izmir
ZIP/Postal Code
009035575
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052642353
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
03223444444
Facility Name
Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(0312) 042000
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 2605)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903123053432
Facility Name
Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)
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
Ankara City Hospital-Medical Oncology ( Site 2601)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903125526000
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00902162803333
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
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7684A-006&&kw=7684A-006
Description
Plain Language Summary
Learn more about this trial
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
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