Back to resultsStudy of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
Primary Purpose
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Olaparib
Placebo for olaparib
Etoposide
Carboplatin
Cisplatin
Paclitaxel
Pemetrexed
Thoracic Radiotherapy
Durvalumab
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring Programmed Cell Death Receptor 1 (PD-1, PD1), Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1), Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2), polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
Eligibility Criteria
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 unable to undergo surgery with curative intent for Stage III NSCLC
- Has no evidence of metastatic disease indicating Stage IV NSCLC
- Has measurable disease as defined by RECIST 1.1
- Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible
- Has provided a 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
- A male participant must agree to use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention unless confirmed to be azoospermic (vasectomized or secondary to medical cause). The length of time required to continue contraception for each study intervention is as follows: Olaparib, platinum doublet, and radiotherapy: 90 days
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees to abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Pembrolizumab: 120 days; Olaparib, platinum doublet, and radiotherapy: 180 days
- Has a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Has adequate pulmonary function tests
- Has adequate organ function
- Has provided written informed consent
Exclusion Criteria:
- Has small cell lung cancer or a mixed tumor with presence of small cell elements
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- Has had documented weight loss >10% (from baseline) in the preceding 3 months
- Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
- Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
- Has had major surgery <4 weeks prior to the first dose of study treatment (except for placement of vascular access)
- Is expected to require any other form of antineoplastic therapy, while on study
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
- Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [GCSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
- Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
- Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
- 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 before, during, and for at least 2 days after administration of pemetrexed
- Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study treatment
- The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (excluding carcinoma-in situ-of the bladder) that have undergone potentially curative therapy
- Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
- 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 or known active Hepatitis C virus infection
- Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
- Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- University of South Alabama, Mitchell Cancer Institute ( Site 0003)
- St. Bernards Medical Center ( Site 0089)Recruiting
- St Joseph Heritage Healthcare-Oncology ( Site 0088)Recruiting
- Long Beach Memorial Medical Center ( Site 0006)Recruiting
- UCLA Hematology/Oncology - Santa Monica ( Site 0013)Recruiting
- St. Joseph Heritage Healthcare Local Lab ( Site 0011)
- Torrance Memorial Physician Network / Cancer Center ( Site 0093)Recruiting
- Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)Recruiting
- Miami VA Healthcare System ( Site 0024)
- Mid Florida Hematology and Oncology Center ( Site 0022)Recruiting
- Orlando Health, UF Health Cancer Center Inc ( Site 0092)Recruiting
- Fort Wayne Medical Oncology and Hematology ( Site 0094)Recruiting
- Parkview Research Center ( Site 0032)Recruiting
- Franciscan Health Lafayette East ( Site 0031)Recruiting
- University of Kentucky ( Site 0096)Recruiting
- Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)Recruiting
- Pikeville Medical Center ( Site 0036)
- Massachusetts General Hospital ( Site 0038)
- Henry Ford Hospital ( Site 0045)
- VA St. Louis Health Care System ( Site 0047)Recruiting
- Washington University Siteman Cancer Center ( Site 0046)Recruiting
- CHI Health St. Francis ( Site 0053)
- Rutgers Cancer Institute of New Jersey ( Site 0054)Recruiting
- The Valley Hospital ( Site 0056)Recruiting
- Montefiore Einstein Center ( Site 0083)
- Novant Health Presbyterian ( Site 0081)Recruiting
- Duke University Medical Center ( Site 0050)
- Piedmont Hematology-Oncology Associates ( Site 0080)Recruiting
- The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)Recruiting
- Fox Chase Cancer Center ( Site 0063)
- Sanford Cancer Center Oncology Clinic ( Site 0066)Recruiting
- Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)Recruiting
- Cancer Care Northwest ( Site 0074)
- Instituto Médico Río Cuarto ( Site 4003)Recruiting
- Clinica Adventista Belgrano-Oncology ( Site 4002)Recruiting
- Queen Elizabeth II Health Sciences Centre ( Site 0100)Recruiting
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)Recruiting
- CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)Recruiting
- McGill University Health Center - Research Institute ( Site 0114)Recruiting
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0Recruiting
- Centro Investigación del Cáncer James Lind ( Site 0202)Recruiting
- OrlandiOncologia ( Site 0201)Recruiting
- Bradfordhill ( Site 0200)Recruiting
- Oncocentro ( Site 0203)Recruiting
- Centro Oncologico Antofagasta ( Site 0204)Recruiting
- Beijing Cancer Hospital ( Site 3224)Recruiting
- Peking Union Medical College Hospital ( Site 3201)
- Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)
- Beijing Cancer Hospital ( Site 3212)Recruiting
- Daping Hospital,Third Military Medical University ( Site 3235)
- Fujian Provincial Cancer Hospital ( Site 3226)
- The First Affiliated Hospital of Xiamen University ( Site 3219)Recruiting
- Peking University Shenzhen Hospital ( Site 3216)Recruiting
- Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)Recruiting
- Henan Cancer Hospital ( Site 3205)
- Wuhan Union Hospital ( Site 3222)
- Hubei Cancer Hospital ( Site 3218)
- Hunan Cancer Hospital ( Site 3238)Recruiting
- Xiangya Hospital of Central South University ( Site 3637)
- Second Xiangya Hospital of Central-South University ( Site 3227)
- Hunan Cancer Hospital ( Site 3225)Recruiting
- Jiangsu Cancer Hospital ( Site 3234)Recruiting
- The Second Affiliated Hospital of Nanchang University ( Site 3206)
- Jilin Cancer Hospital ( Site 3230)Recruiting
- Shanghai Chest Hospital ( Site 3207)
- Zhongshan Hospital Fudan University ( Site 3220)Recruiting
- Shanghai Pulmonary Hospital ( Site 3203)Recruiting
- West China Hospital of Sichuan University ( Site 3202)
- Tianjin Medical University Cancer Institute & Hospital ( Site 3204)
- The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)Recruiting
- Masarykuv onkologicky ustav ( Site 2206)Recruiting
- Fakultni nemocnice Ostrava ( Site 2201)Recruiting
- Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)Recruiting
- Fakultni nemocnice v Motole ( Site 2210)Recruiting
- Nemocnice Na Plesi s.r.o. ( Site 2202)
- Krajska nemocnice Liberec, a.s. ( Site 2209)Recruiting
- Vseobecna fakultni nemocnice v Praze ( Site 2208)Recruiting
- Nemocnice Na Bulovce ( Site 2205)Recruiting
- North Estonia Medical Centre Foundation ( Site 1601)Recruiting
- Tartu University Hospital ( Site 1600)Recruiting
- Clinique Clairval ( Site 0802)Recruiting
- C.H.R.U. de Brest - Hopital Morvan ( Site 0806)Recruiting
- Centre Hospitalier Annecy Genevois ( Site 0811)Recruiting
- Clinique Teissier Groupe ( Site 0808)Recruiting
- Hopital Avicenne ( Site 0803)
- Clinique de l'Europe-Service de pneumologie ( Site 0816)Recruiting
- H.I.A. Sainte-Anne ( Site 0815)Recruiting
- CHD Vendee ( Site 0807)Recruiting
- Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)Recruiting
- Johannes Wesling Klinikum Minden ( Site 0908)Recruiting
- GEHO Muenster ( Site 0910)
- Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)Recruiting
- LungenClinic Grosshansdorf GmbH ( Site 0901)Recruiting
- Zentralklinik Bad Berka GmbH ( Site 0905)Recruiting
- Universitaetsklinikum Jena ( Site 0911)
- Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)Recruiting
- Katholisches Marienkrankenhaus gGmbH ( Site 0902)Recruiting
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)Recruiting
- Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)Recruiting
- Petz Aladar Megyei Oktato Korhaz ( Site 2306)Recruiting
- Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)Recruiting
- Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)Recruiting
- Azienda Ospedaliera Umberto I- Torrette ( Site 1009)Recruiting
- Azienda Ospedaliero Universitaria Careggi ( Site 1001)Recruiting
- Istituto Clinico Humanitas Research Hospital ( Site 1000)Recruiting
- Azienda Ospedaliera Vito Fazzi ( Site 1003)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)Recruiting
- Policlinico di Modena ( Site 1007)Recruiting
- Policlinico Agostino Gemelli ( Site 1002)Recruiting
- A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)Recruiting
- Kurume University Hospital ( Site 3112)
- Kobe Minimally Invasive Cancer Center ( Site 3100)
- Kanagawa Cancer Center ( Site 3101)
- Kansai Medical University Hospital ( Site 3103)
- Osaka Medical and Pharmaceutical University Hospital ( Site 3110)
- National Hospital Organization Kyushu Cancer Center ( Site 3104)
- Niigata Cancer Center Hospital ( Site 3109)
- Osaka International Cancer Institute ( Site 3106)
- Juntendo University Hospital ( Site 3111)
- Tokyo Metropolitan Komagome Hospital ( Site 3108)
- The Cancer Institute Hospital of JFCR ( Site 3107)
- Showa University Hospital ( Site 3105)
- Chungbuk National University Hospital ( Site 2802)Recruiting
- National Cancer Center ( Site 2800)
- The Catholic University of Korea St. Vincent s Hospital ( Site 2805)
- Seoul National University Bundang Hospital ( Site 2801)
- Ajou University Hospital ( Site 2803)
- Gyeongsang National University Hospital ( Site 2804)
- Keimyung University Dongsan Hospital ( Site 2807)
- Kangbuk Samsung Hospital ( Site 2806)Recruiting
- Severance Hospital Yonsei University Health System ( Site 2808)Recruiting
- Pauls Stradins Clinical University Hospital ( Site 1501)Recruiting
- Riga East Clinical University Hospital ( Site 1500)Recruiting
- Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)Recruiting
- National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)Recruiting
- Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)Recruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)Recruiting
- CLIMERS Clinical Medical Research ( Site 0506)Recruiting
- Instituto Nacional de Cancerologia ( Site 0502)Recruiting
- Akershus Universitetssykehus HF ( Site 1106)Recruiting
- Vestre Viken HF Drammen Sykehus ( Site 1101)Recruiting
- Sykehuset Oestfold ( Site 1107)
- Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)Recruiting
- Oslo Universitetssykehus HF. Ulleval ( Site 1100)Recruiting
- Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)
- Oncosalud ( Site 0605)Recruiting
- Detecta Clínica ( Site 0607)Recruiting
- IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)Recruiting
- Clinica San Gabriel ( Site 0601)
- Hospital Nacional Cayetano Heredia ( Site 0602)Recruiting
- Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Recruiting
- Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)Recruiting
- SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)Recruiting
- Spitalul Universitar de Urgenta Bucuresti ( Site 2508)Recruiting
- Gral Medical SRL-Medical Oncology ( Site 2511)Recruiting
- Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)Recruiting
- S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)Recruiting
- Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2510)Recruiting
- Radiology Therapeutic Center-Oncology ( Site 2502)Recruiting
- Policlinica Oncomed SRL ( Site 2504)Recruiting
- S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)Recruiting
- S.C.Focus Lab Plus S.R.L ( Site 2500)Recruiting
- Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
- Institutul Regional de Oncologie Iasi ( Site 2505)
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)
- MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)
- Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)
- Medical institute named after Berezin Sergey ( Site 1906)
- Sverdlovsk Regional Oncology Hospital ( Site 1909)
- Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)
- Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)
- Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)
- Hospital Universitario Quiron Madrid ( Site 1200)Recruiting
- H.R.U Málaga - Hospital General ( Site 1206)Recruiting
- H.U. Vall de Hebron ( Site 1201)Recruiting
- Hospital Clinic de Barcelona ( Site 1204)Recruiting
- Hospital Universitario Virgen Macarena ( Site 1205)Recruiting
- Hospital Universitario La Fe ( Site 1203)
- Chulalongkorn University ( Site 3003)Recruiting
- Ramathibodi Hospital. ( Site 3000)Recruiting
- Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)Recruiting
- Srinagarind Hospital. Khon Kaen University ( Site 3002)Recruiting
- Ankara Bilkent Sehir Hastanesi ( Site 2002)Recruiting
- Memorial Ankara Hastanesi ( Site 2006)Recruiting
- Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)Recruiting
- Medipol Universite Hastanesi ( Site 2003)Recruiting
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)Recruiting
- Ege University Medical Faculty ( Site 2005)Recruiting
- Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
- SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (
- Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
- LLC Ukrainian Center of Tomotherapy ( Site 2105)
- Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
- National Cancer Institute of the MoH of Ukraine ( Site 2101)
- Medical Center Verum ( Site 2106)
- Kyiv City Clinical Oncology Center ( Site 2100)
- Weston Park Hospital ( Site 1406)Recruiting
- University College Hospital NHS Foundation Trust ( Site 1403)Recruiting
- Guys and St Thomas NHS Foundation Trust ( Site 1410)Recruiting
- Royal Marsden Hospital (Sutton) ( Site 1407)Recruiting
- Southampton General Hospital ( Site 1400)Recruiting
- Leeds Teaching Hospitals NHS Trust ( Site 1401)Recruiting
- Christie NHS Foundation Trust ( Site 1409)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo
pembrolizumab+chemoradiation→pembrolizumab+olaparib
chemoradiation→durvalumab
Arm Description
Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.
Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.
Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Secondary Outcome Measures
Incidence of Adverse Events (AE)
An AE is defined as 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.
Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)
An AE is defined as as 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.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants who have achieved a Complete Response (CR) or a Partial Response (PR).
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
DOR is defined as the time from first documented evidence of Complete Response (CR) or a Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.
Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scale scores will be presented.
Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score
The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough scale score will be presented.
Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain scale score will be presented.
Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). 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, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea scale score will be presented.
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Participant responses 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. The change from baseline in the EORTC QLQ-C30 physical functioning scale score will be presented.
Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses 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. The change from baseline in the EORTC QLQ-C30 role functioning scale score will be presented.
Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 29 and 30 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 1 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.
TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 10 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.
TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Item 8 scale score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). 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, with a lower score indicating a better outcome.
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 1-5 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Participant responses 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.
TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 6-7 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04380636
Brief Title
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
Official Title
A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
July 6, 2026 (Anticipated)
Study Completion Date
July 6, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:
Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
Keywords
Programmed Cell Death Receptor 1 (PD-1, PD1), Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1), Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2), polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
870 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.
Arm Title
pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm Type
Experimental
Arm Description
Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.
Arm Title
chemoradiation→durvalumab
Arm Type
Active Comparator
Arm Description
Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
LYNPARZA®, MK-7339, AZD2281, KU-0059436
Intervention Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo for olaparib
Intervention Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VEPESID®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
ALIMTA®
Intervention Description
IV infusion
Intervention Type
Radiation
Intervention Name(s)
Thoracic Radiotherapy
Intervention Description
external beam radiation
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
IMFINZI®
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Description
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 48 months
Title
Overall Survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to approximately 72 months
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AE)
Description
An AE is defined as 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.
Time Frame
Up to approximately 72 months
Title
Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)
Description
An AE is defined as as 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.
Time Frame
Up to approximately 72 months
Title
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Description
ORR is defined as the percentage of participants who have achieved a Complete Response (CR) or a Partial Response (PR).
Time Frame
Up to approximately 72 months
Title
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Description
DOR is defined as the time from first documented evidence of Complete Response (CR) or a Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 72 months
Title
Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scale scores will be presented.
Time Frame
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
Title
Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score
Description
The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough scale score will be presented.
Time Frame
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
Title
Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
Description
The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain scale score will be presented.
Time Frame
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
Title
Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). 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, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea scale score will be presented.
Time Frame
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
Title
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Participant responses 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. The change from baseline in the EORTC QLQ-C30 physical functioning scale score will be presented.
Time Frame
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
Title
Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses 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. The change from baseline in the EORTC QLQ-C30 role functioning scale score will be presented.
Time Frame
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
Title
Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score
Description
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 29 and 30 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). 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
Up to approximately 72 months post randomization
Title
TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score
Description
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 1 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.
Time Frame
Up to approximately 72 months post randomization
Title
TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
Description
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 10 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.
Time Frame
Up to approximately 72 months post randomization
Title
TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
Description
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Item 8 scale score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). 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, with a lower score indicating a better outcome.
Time Frame
Up to approximately 72 months post randomization
Title
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
Description
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 1-5 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Participant responses 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
Up to approximately 72 months post randomization
Title
TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
Description
TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 6-7 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses 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
Up to approximately 72 months post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 unable to undergo surgery with curative intent for Stage III NSCLC
Has no evidence of metastatic disease indicating Stage IV NSCLC
Has measurable disease as defined by RECIST 1.1
Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible
Has provided a 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
A male participant must agree to use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention unless confirmed to be azoospermic (vasectomized or secondary to medical cause). The length of time required to continue contraception for each study intervention is as follows: Olaparib, platinum doublet, and radiotherapy: 90 days
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees to abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Pembrolizumab: 120 days; Olaparib, platinum doublet, and radiotherapy: 180 days
Has a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Has adequate pulmonary function tests
Has adequate organ function
Has provided written informed consent
Exclusion Criteria:
Has small cell lung cancer or a mixed tumor with presence of small cell elements
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
Has had documented weight loss >10% (from baseline) in the preceding 3 months
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
Has had major surgery <4 weeks prior to the first dose of study treatment (except for placement of vascular access)
Is expected to require any other form of antineoplastic therapy, while on study
Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [GCSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
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 before, during, and for at least 2 days after administration of pemetrexed
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
Has received an investigational agent or has used an investigational device within 4 weeks prior to study treatment
The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (excluding carcinoma-in situ-of the bladder) that have undergone potentially curative therapy
Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
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 or known active Hepatitis C virus infection
Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
Has had an allogenic tissue/solid organ transplant
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
University of South Alabama, Mitchell Cancer Institute ( Site 0003)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Completed
Facility Name
St. Bernards Medical Center ( Site 0089)
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
870-207-8177
Facility Name
St Joseph Heritage Healthcare-Oncology ( Site 0088)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
714-446-7900
Facility Name
Long Beach Memorial Medical Center ( Site 0006)
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
562-933-7866
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0013)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-829-5471
Facility Name
St. Joseph Heritage Healthcare Local Lab ( Site 0011)
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Completed
Facility Name
Torrance Memorial Physician Network / Cancer Center ( Site 0093)
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-750-3376
Facility Name
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-265-4325
Facility Name
Miami VA Healthcare System ( Site 0024)
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Completed
Facility Name
Mid Florida Hematology and Oncology Center ( Site 0022)
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
Orlando Health, UF Health Cancer Center Inc ( Site 0092)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
321-841-1869
Facility Name
Fort Wayne Medical Oncology and Hematology ( Site 0094)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
260-436-0800
Facility Name
Parkview Research Center ( Site 0032)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
833-724-8326
Facility Name
Franciscan Health Lafayette East ( Site 0031)
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-528-1580
Facility Name
University of Kentucky ( Site 0096)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-257-3379
Facility Name
Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-629-4673
Facility Name
Pikeville Medical Center ( Site 0036)
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital ( Site 0038)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Henry Ford Hospital ( Site 0045)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Completed
Facility Name
VA St. Louis Health Care System ( Site 0047)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-289-7690
Facility Name
Washington University Siteman Cancer Center ( Site 0046)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-747-7222
Facility Name
CHI Health St. Francis ( Site 0053)
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Completed
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0054)
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
The Valley Hospital ( Site 0056)
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
201-447-8000
Facility Name
Montefiore Einstein Center ( Site 0083)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Completed
Facility Name
Novant Health Presbyterian ( Site 0081)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
704-384-8823
Facility Name
Duke University Medical Center ( Site 0050)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Completed
Facility Name
Piedmont Hematology-Oncology Associates ( Site 0080)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
336-277-8800
Facility Name
The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
513-585-0844
Facility Name
Fox Chase Cancer Center ( Site 0063)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Completed
Facility Name
Sanford Cancer Center Oncology Clinic ( Site 0066)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
605-328-8000
Facility Name
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
206-277-3101
Facility Name
Cancer Care Northwest ( Site 0074)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Completed
Facility Name
Instituto Médico Río Cuarto ( Site 4003)
City
Río Cuarto
State/Province
Cordoba
ZIP/Postal Code
X5800AEV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
54351153819050
Facility Name
Clinica Adventista Belgrano-Oncology ( Site 4002)
City
Caba
ZIP/Postal Code
1430
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491132682903
Facility Name
Queen Elizabeth II Health Sciences Centre ( Site 0100)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9024738317
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5148908000 ext 24348
Facility Name
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+15143453511
Facility Name
McGill University Health Center - Research Institute ( Site 0114)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-934-1934 ext 64802
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4185254444
Facility Name
Centro Investigación del Cáncer James Lind ( 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
+56974316500
Facility Name
OrlandiOncologia ( Site 0201)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500713
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56992214787
Facility Name
Bradfordhill ( Site 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 ( Site 0203)
City
Vina 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
+56992369820
Facility Name
Centro Oncologico Antofagasta ( Site 0204)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56994198125
Facility Name
Beijing Cancer Hospital ( Site 3224)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8601088196479
Facility Name
Peking Union Medical College Hospital ( Site 3201)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer Hospital ( Site 3212)
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
+8601088196984
Facility Name
Daping Hospital,Third Military Medical University ( Site 3235)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fujian Provincial Cancer Hospital ( Site 3226)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 3219)
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
0592-2137572
Facility Name
Peking University Shenzhen Hospital ( Site 3216)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613823394076
Facility Name
Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518116
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0755-66619602
Facility Name
Henan Cancer Hospital ( Site 3205)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wuhan Union Hospital ( Site 3222)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hubei Cancer Hospital ( Site 3218)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Cancer Hospital ( Site 3238)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0731-88651900
Facility Name
Xiangya Hospital of Central South University ( Site 3637)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Xiangya Hospital of Central-South University ( Site 3227)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Cancer Hospital ( Site 3225)
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
0731-88651900
Facility Name
Jiangsu Cancer Hospital ( Site 3234)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613913909043
Facility Name
The Second Affiliated Hospital of Nanchang University ( Site 3206)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jilin Cancer Hospital ( Site 3230)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86043185879120
Facility Name
Shanghai Chest Hospital ( Site 3207)
City
Shangai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhongshan Hospital Fudan University ( Site 3220)
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
13601783113
Facility Name
Shanghai Pulmonary Hospital ( Site 3203)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-65115006(2131)
Facility Name
West China Hospital of Sichuan University ( Site 3202)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
510115
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 3204)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613957162839
Facility Name
Masarykuv onkologicky ustav ( Site 2206)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420543132450
Facility Name
Fakultni nemocnice Ostrava ( Site 2201)
City
Ostrava
State/Province
Ostrava Mesto
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420597372124
Facility Name
Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)
City
PRague
State/Province
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420724318145
Facility Name
Fakultni nemocnice v Motole ( Site 2210)
City
Praha
State/Province
Praha, Hlavni Mesto
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420224434700
Facility Name
Nemocnice Na Plesi s.r.o. ( Site 2202)
City
Nova Ves pod Plesi
State/Province
Pribram
ZIP/Postal Code
262 04
Country
Czechia
Individual Site Status
Completed
Facility Name
Krajska nemocnice Liberec, a.s. ( Site 2209)
City
Liberec
ZIP/Postal Code
468 63
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420606540548
Facility Name
Vseobecna fakultni nemocnice v Praze ( Site 2208)
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420224962219
Facility Name
Nemocnice Na Bulovce ( Site 2205)
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420266082267
Facility Name
North Estonia Medical Centre Foundation ( Site 1601)
City
Tallin
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
372171792
Facility Name
Tartu University Hospital ( Site 1600)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3725513443
Facility Name
Clinique Clairval ( Site 0802)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0033496196230
Facility Name
C.H.R.U. de Brest - Hopital Morvan ( Site 0806)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33298223578
Facility Name
Centre Hospitalier Annecy Genevois ( Site 0811)
City
Epagny Metz Tessy
State/Province
Haute-Savoie
ZIP/Postal Code
74730
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33450636603
Facility Name
Clinique Teissier Groupe ( Site 0808)
City
Valenciennes
State/Province
Nord
ZIP/Postal Code
59304
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3327142434
Facility Name
Hopital Avicenne ( Site 0803)
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93000
Country
France
Individual Site Status
Completed
Facility Name
Clinique de l'Europe-Service de pneumologie ( Site 0816)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33360125235
Facility Name
H.I.A. Sainte-Anne ( Site 0815)
City
Toulon
State/Province
Var
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33483162916
Facility Name
CHD Vendee ( Site 0807)
City
La Roche sur Yon
State/Province
Vendee
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33251446161
Facility Name
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4962215634954
Facility Name
Johannes Wesling Klinikum Minden ( Site 0908)
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4957179054253
Facility Name
GEHO Muenster ( Site 0910)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48153
Country
Germany
Individual Site Status
Completed
Facility Name
Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41462
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49213152953002
Facility Name
LungenClinic Grosshansdorf GmbH ( Site 0901)
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
+491026012101
Facility Name
Zentralklinik Bad Berka GmbH ( Site 0905)
City
Bad Berka
State/Province
Thuringen
ZIP/Postal Code
99437
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4936458543122
Facility Name
Universitaetsklinikum Jena ( Site 0911)
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Completed
Facility Name
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4930450553004
Facility Name
Katholisches Marienkrankenhaus gGmbH ( Site 0902)
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+494025462508
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003676516719
Facility Name
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0036704533531
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 2306)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
96507900 ext4141
Facility Name
Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0036703288101
Facility Name
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0036302005233
Facility Name
Azienda Ospedaliera Umberto I- Torrette ( Site 1009)
City
Torrette
State/Province
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390715964169
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 1001)
City
Florence
State/Province
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390557947192
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 1000)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390282244591
Facility Name
Azienda Ospedaliera Vito Fazzi ( Site 1003)
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00390832661962
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223903813
Facility Name
Policlinico di Modena ( Site 1007)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390594223864
Facility Name
Policlinico Agostino Gemelli ( Site 1002)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630156318
Facility Name
A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390432554550
Facility Name
Kurume University Hospital ( Site 3112)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kobe Minimally Invasive Cancer Center ( Site 3100)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kanagawa Cancer Center ( Site 3101)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kansai Medical University Hospital ( Site 3103)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 3110)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 3104)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Niigata Cancer Center Hospital ( Site 3109)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka International Cancer Institute ( Site 3106)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Juntendo University Hospital ( Site 3111)
City
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 3108)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
The Cancer Institute Hospital of JFCR ( Site 3107)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Showa University Hospital ( Site 3105)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Chungbuk National University Hospital ( Site 2802)
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
+82432696015
Facility Name
National Cancer Center ( Site 2800)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
The Catholic University of Korea St. Vincent s Hospital ( Site 2805)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Bundang Hospital ( Site 2801)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Ajou University Hospital ( Site 2803)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Gyeongsang National University Hospital ( Site 2804)
City
Jinju-si
State/Province
Kyongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Keimyung University Dongsan Hospital ( Site 2807)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kangbuk Samsung Hospital ( Site 2806)
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220011859
Facility Name
Severance Hospital Yonsei University Health System ( Site 2808)
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
+82222280870
Facility Name
Pauls Stradins Clinical University Hospital ( Site 1501)
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37129410710
Facility Name
Riga East Clinical University Hospital ( Site 1500)
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+37129455458
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
37037326457
Facility Name
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)
City
Vilnius
State/Province
Vilniaus Miestas
ZIP/Postal Code
08660
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
37052786748
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
523315145351
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8183338111
Facility Name
CLIMERS Clinical Medical Research ( Site 0506)
City
Orizaba
State/Province
Veracruz
ZIP/Postal Code
94300
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+522727282900
Facility Name
Instituto Nacional de Cancerologia ( Site 0502)
City
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+525513150894
Facility Name
Akershus Universitetssykehus HF ( Site 1106)
City
Lorenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4767960000
Facility Name
Vestre Viken HF Drammen Sykehus ( Site 1101)
City
Drammen
State/Province
Buskerud
ZIP/Postal Code
3004
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4732862464
Facility Name
Sykehuset Oestfold ( Site 1107)
City
Gralum
State/Province
Ostfold
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Completed
Facility Name
Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4751518000
Facility Name
Oslo Universitetssykehus HF. Ulleval ( Site 1100)
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4722934809
Facility Name
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)
City
Arequipa
State/Province
Ariqipa
ZIP/Postal Code
04001
Country
Peru
Individual Site Status
Completed
Facility Name
Oncosalud ( Site 0605)
City
Lima
State/Province
Muni Metro De Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5112053500
Facility Name
Detecta Clínica ( Site 0607)
City
Surquillo
State/Province
Muni Metro De Lima
ZIP/Postal Code
15038
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5112175100 e312
Facility Name
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51997881134
Facility Name
Clinica San Gabriel ( Site 0601)
City
Lima
ZIP/Postal Code
15088
Country
Peru
Individual Site Status
Completed
Facility Name
Hospital Nacional Cayetano Heredia ( Site 0602)
City
Lima
ZIP/Postal Code
15102
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51 942 499 515
Facility Name
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48256403485
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48225463066
Facility Name
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48224800800
Facility Name
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48895398428
Facility Name
Spitalul Universitar de Urgenta Bucuresti ( Site 2508)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40216012610
Facility Name
Gral Medical SRL-Medical Oncology ( Site 2511)
City
București
State/Province
Bucuresti
ZIP/Postal Code
031422
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40726273762
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40745976913
Facility Name
S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)
City
Comuna Floresti
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"-Medical Oncology ( Site 2510)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200746
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722161545
Facility Name
Radiology Therapeutic Center-Oncology ( Site 2502)
City
Otopeni
State/Province
Ilfov
ZIP/Postal Code
075100
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3640723171603
Facility Name
Policlinica Oncomed SRL ( Site 2504)
City
Timisoara
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
+40723401453
Facility Name
S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)
City
Timișoara
State/Province
Timis
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40745146020
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 2500)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40721298677
Facility Name
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Completed
Facility Name
Institutul Regional de Oncologie Iasi ( Site 2505)
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Completed
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603081
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Medical institute named after Berezin Sergey ( Site 1906)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Sverdlovsk Regional Oncology Hospital ( Site 1909)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Quiron Madrid ( Site 1200)
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
+34914521987
Facility Name
H.R.U Málaga - Hospital General ( Site 1206)
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 95 129 14 25
Facility Name
H.U. Vall de Hebron ( Site 1201)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934894158
Facility Name
Hospital Clinic de Barcelona ( Site 1204)
City
Barcelona
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
Hospital Universitario Virgen Macarena ( Site 1205)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955926578
Facility Name
Hospital Universitario La Fe ( Site 1203)
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Completed
Facility Name
Chulalongkorn University ( Site 3003)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6622564533
Facility Name
Ramathibodi Hospital. ( Site 3000)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6624197388
Facility Name
Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6653938887
Facility Name
Srinagarind Hospital. Khon Kaen University ( Site 3002)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6643204432
Facility Name
Ankara Bilkent Sehir Hastanesi ( Site 2002)
City
Ankara
State/Province
Adana
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905555306271
Facility Name
Memorial Ankara Hastanesi ( Site 2006)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905067521275
Facility Name
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324167355
Facility Name
Medipol Universite Hastanesi ( Site 2003)
City
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
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905063509061
Facility Name
Ege University Medical Faculty ( Site 2005)
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905322202675
Facility Name
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Individual Site Status
Suspended
Facility Name
SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61024
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
City
Antonivka Village
State/Province
Khersonska Oblast
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Completed
Facility Name
LLC Ukrainian Center of Tomotherapy ( Site 2105)
City
Kropyvnytskyi
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25011
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
City
Kapitanivka Village
State/Province
Kyivska Oblast
ZIP/Postal Code
08111
Country
Ukraine
Individual Site Status
Suspended
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 2101)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center Verum ( Site 2106)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03039
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv City Clinical Oncology Center ( Site 2100)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Weston Park Hospital ( Site 1406)
City
Sheffield
State/Province
Derbyshire
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
447753314683
Facility Name
University College Hospital NHS Foundation Trust ( Site 1403)
City
London-Camden
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442034474698
Facility Name
Guys and St Thomas NHS Foundation Trust ( Site 1410)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+02071882006
Facility Name
Royal Marsden Hospital (Sutton) ( Site 1407)
City
London
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442086426011
Facility Name
Southampton General Hospital ( Site 1400)
City
Southampton
State/Province
Worcestershire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442381206184
Facility Name
Leeds Teaching Hospitals NHS Trust ( Site 1401)
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441132068225
Facility Name
Christie NHS Foundation Trust ( Site 1409)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441619182459
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
Citations:
PubMed Identifier
35618629
Citation
Jabbour SK, Cho BC, Bria E, Kato T, Bhosle J, Gainor JF, Reguart N, Wang L, Morgensztern D, Shentu Y, Kim SJ, Souza F, Reck M. Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Sep;23(6):e342-e346. doi: 10.1016/j.cllc.2022.04.003. Epub 2022 Apr 29.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
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