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)

Trial 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)

NCT ID: NCT04380636

Condition: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Paclitaxel
Etoposide
Carboplatin
Pembrolizumab
Pemetrexed
Durvalumab
Olaparib

Conditions: 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

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Biological
Intervention name: Pembrolizumab
Description: intravenous (IV) infusion
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Other name: KEYTRUDA®

Other name: MK-3475

Intervention type: Drug
Intervention name: Olaparib
Description: oral tablets
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib

Other name: LYNPARZA®

Other name: MK-7339

Other name: AZD2281

Other name: KU-0059436

Intervention type: Drug
Intervention name: Placebo for olaparib
Description: oral tablets
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Intervention type: Drug
Intervention name: Etoposide
Description: IV infusion
Arm group label: chemoradiation→durvalumab
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Other name: VEPESID®

Intervention type: Drug
Intervention name: Carboplatin
Description: IV infusion
Arm group label: chemoradiation→durvalumab
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Other name: PARAPLATIN®

Intervention type: Drug
Intervention name: Cisplatin
Description: IV infusion
Arm group label: chemoradiation→durvalumab
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Other name: PLATINOL®

Intervention type: Drug
Intervention name: Paclitaxel
Description: IV infusion
Arm group label: chemoradiation→durvalumab
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Other name: TAXOL®

Intervention type: Drug
Intervention name: Pemetrexed
Description: IV infusion
Arm group label: chemoradiation→durvalumab
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Other name: ALIMTA®

Intervention type: Radiation
Intervention name: Thoracic Radiotherapy
Description: external beam radiation
Arm group label: chemoradiation→durvalumab
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib
Arm group label: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

Intervention type: Drug
Intervention name: Durvalumab
Description: IV infusion
Arm group label: chemoradiation→durvalumab

Other name: IMFINZI®

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: 1. 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) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of South Alabama, Mitchell Cancer Institute ( Site 0003)

Address:
City: Mobile
Zip: 36604
Country: United States

Facility:
Name: St. Bernards Medical Center ( Site 0089)

Address:
City: Jonesboro
Zip: 72401
Country: United States

Facility:
Name: St Joseph Heritage Healthcare-Oncology ( Site 0088)

Address:
City: Fullerton
Zip: 92835
Country: United States

Facility:
Name: Long Beach Memorial Medical Center ( Site 0006)

Address:
City: Long Beach
Zip: 90806
Country: United States

Facility:
Name: UCLA Hematology/Oncology - Santa Monica ( Site 0013)

Address:
City: Los Angeles
Zip: 90404
Country: United States

Facility:
Name: St. Joseph Heritage Healthcare Local Lab ( Site 0011)

Address:
City: Santa Rosa
Zip: 95403
Country: United States

Facility:
Name: Torrance Memorial Physician Network / Cancer Center ( Site 0093)

Address:
City: Torrance
Zip: 90505
Country: United States

Facility:
Name: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)

Address:
City: Hollywood
Zip: 33021
Country: United States

Facility:
Name: Miami VA Healthcare System ( Site 0024)

Address:
City: Miami
Zip: 33125
Country: United States

Facility:
Name: Mid Florida Hematology and Oncology Center ( Site 0022)

Address:
City: Orange City
Zip: 32763
Country: United States

Facility:
Name: Orlando Health, UF Health Cancer Center Inc ( Site 0092)

Address:
City: Orlando
Zip: 32806
Country: United States

Facility:
Name: Fort Wayne Medical Oncology and Hematology ( Site 0094)

Address:
City: Fort Wayne
Zip: 46804
Country: United States

Facility:
Name: Parkview Research Center ( Site 0032)

Address:
City: Fort Wayne
Zip: 46845
Country: United States

Facility:
Name: Franciscan Health Lafayette East ( Site 0031)

Address:
City: Lafayette
Zip: 47905
Country: United States

Facility:
Name: University of Kentucky ( Site 0096)

Address:
City: Lexington
Zip: 40536
Country: United States

Facility:
Name: Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)

Address:
City: Louisville
Zip: 40241
Country: United States

Facility:
Name: Pikeville Medical Center ( Site 0036)

Address:
City: Pikeville
Zip: 41501
Country: United States

Facility:
Name: Massachusetts General Hospital ( Site 0038)

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Henry Ford Hospital ( Site 0045)

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: VA St. Louis Health Care System ( Site 0047)

Address:
City: Saint Louis
Zip: 63106
Country: United States

Facility:
Name: Washington University Siteman Cancer Center ( Site 0046)

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: CHI Health St. Francis ( Site 0053)

Address:
City: Grand Island
Zip: 68803
Country: United States

Facility:
Name: Rutgers Cancer Institute of New Jersey ( Site 0054)

Address:
City: New Brunswick
Zip: 08901
Country: United States

Facility:
Name: The Valley Hospital ( Site 0056)

Address:
City: Paramus
Zip: 07652
Country: United States

Facility:
Name: Montefiore Einstein Center ( Site 0083)

Address:
City: Bronx
Zip: 10467
Country: United States

Facility:
Name: Novant Health Presbyterian ( Site 0081)

Address:
City: Charlotte
Zip: 28204
Country: United States

Facility:
Name: Duke University Medical Center ( Site 0050)

Address:
City: Durham
Zip: 27710
Country: United States

Facility:
Name: Piedmont Hematology-Oncology Associates ( Site 0080)

Address:
City: Winston-Salem
Zip: 27103
Country: United States

Facility:
Name: The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)

Address:
City: Cincinnati
Zip: 45219
Country: United States

Facility:
Name: Fox Chase Cancer Center ( Site 0063)

Address:
City: Philadelphia
Zip: 19111
Country: United States

Facility:
Name: Sanford Cancer Center Oncology Clinic ( Site 0066)

Address:
City: Sioux Falls
Zip: 57104
Country: United States

Facility:
Name: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)

Address:
City: Seattle
Zip: 98108
Country: United States

Facility:
Name: Cancer Care Northwest ( Site 0074)

Address:
City: Spokane Valley
Zip: 99216
Country: United States

Facility:
Name: Instituto Médico Río Cuarto ( Site 4003)

Address:
City: Río Cuarto
Zip: X5800AEV
Country: Argentina

Facility:
Name: Clinica Adventista Belgrano-Oncology ( Site 4002)

Address:
City: Caba
Zip: 1430
Country: Argentina

Facility:
Name: Queen Elizabeth II Health Sciences Centre ( Site 0100)

Address:
City: Halifax
Zip: B3H 1V7
Country: Canada

Facility:
Name: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)

Address:
City: Montreal
Zip: H2X 3E4
Country: Canada

Facility:
Name: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)

Address:
City: Montreal
Zip: H3T 1M5
Country: Canada

Facility:
Name: McGill University Health Center - Research Institute ( Site 0114)

Address:
City: Montreal
Zip: H4A 3J1
Country: Canada

Facility:
Name: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Address:
City: Quebec
Zip: G1J 1Z4
Country: Canada

Facility:
Name: Centro Investigación del Cáncer James Lind ( Site 0202)

Address:
City: Temuco
Zip: 4800827
Country: Chile

Facility:
Name: OrlandiOncologia ( Site 0201)

Address:
City: Santiago
Zip: 7500713
Country: Chile

Facility:
Name: Bradfordhill ( Site 0200)

Address:
City: Santiago
Zip: 8420383
Country: Chile

Facility:
Name: Oncocentro ( Site 0203)

Address:
City: Vina del Mar
Zip: 2520598
Country: Chile

Facility:
Name: Bradford Hill Norte ( Site 0204)

Address:
City: Antofagasta
Zip: 1240000
Country: Chile

Facility:
Name: Beijing Cancer Hospital ( Site 3224)

Address:
City: Beijing
Zip: 100001
Country: China

Facility:
Name: Peking Union Medical College Hospital ( Site 3201)

Address:
City: Beijing
Zip: 100006
Country: China

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Beijing Cancer Hospital ( Site 3212)

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Daping Hospital,Third Military Medical University ( Site 3235)

Address:
City: Chongqing
Zip: 400042
Country: China

Facility:
Name: Fujian Provincial Cancer Hospital ( Site 3226)

Address:
City: Fuzhou
Zip: 350014
Country: China

Facility:
Name: The First Affiliated Hospital of Xiamen University ( Site 3219)

Address:
City: Xiamen
Zip: 361003
Country: China

Facility:
Name: Peking University Shenzhen Hospital ( Site 3216)

Address:
City: Shenzhen
Zip: 518036
Country: China

Facility:
Name: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)

Address:
City: Shenzhen
Zip: 518116
Country: China

Facility:
Name: Henan Cancer Hospital ( Site 3205)

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Wuhan Union Hospital ( Site 3222)

Address:
City: Wuhan
Zip: 430022
Country: China

Facility:
Name: Hubei Cancer Hospital ( Site 3218)

Address:
City: Wuhan
Zip: 430079
Country: China

Facility:
Name: Hunan Cancer Hospital ( Site 3238)

Address:
City: Changsha
Zip: 410006
Country: China

Facility:
Name: Xiangya Hospital of Central South University ( Site 3637)

Address:
City: Changsha
Zip: 410008
Country: China

Facility:
Name: Second Xiangya Hospital of Central-South University ( Site 3227)

Address:
City: Changsha
Zip: 410011
Country: China

Facility:
Name: Hunan Cancer Hospital ( Site 3225)

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Jiangsu Cancer Hospital ( Site 3234)

Address:
City: Nanjing
Zip: 210000
Country: China

Facility:
Name: The Second Affiliated Hospital of Nanchang University ( Site 3206)

Address:
City: Nanchang
Zip: 330006
Country: China

Facility:
Name: Jilin Cancer Hospital ( Site 3230)

Address:
City: Changchun
Zip: 130000
Country: China

Facility:
Name: Shanghai Chest Hospital ( Site 3207)

Address:
City: Shangai
Zip: 200030
Country: China

Facility:
Name: Zhongshan Hospital Fudan University ( Site 3220)

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: Shanghai Pulmonary Hospital ( Site 3203)

Address:
City: Shanghai
Zip: 200443
Country: China

Facility:
Name: West China Hospital of Sichuan University ( Site 3202)

Address:
City: Chengdu
Zip: 510115
Country: China

Facility:
Name: Tianjin Medical University Cancer Institute & Hospital ( Site 3204)

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)

Address:
City: Hangzhou
Zip: 310003
Country: China

Facility:
Name: Masarykuv onkologicky ustav ( Site 2206)

Address:
City: Brno
Zip: 656 53
Country: Czechia

Facility:
Name: Fakultni nemocnice Ostrava ( Site 2201)

Address:
City: Ostrava
Zip: 708 52
Country: Czechia

Facility:
Name: Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)

Address:
City: PRague
Zip: 10034
Country: Czechia

Facility:
Name: Fakultni nemocnice v Motole ( Site 2210)

Address:
City: Praha
Zip: 150 06
Country: Czechia

Facility:
Name: Nemocnice Na Plesi s.r.o. ( Site 2202)

Address:
City: Nova Ves pod Plesi
Zip: 262 04
Country: Czechia

Facility:
Name: Krajska nemocnice Liberec, a.s. ( Site 2209)

Address:
City: Liberec
Zip: 468 63
Country: Czechia

Facility:
Name: Vseobecna fakultni nemocnice v Praze ( Site 2208)

Address:
City: Praha 2
Zip: 128 08
Country: Czechia

Facility:
Name: Nemocnice Na Bulovce ( Site 2205)

Address:
City: Praha 8
Zip: 180 81
Country: Czechia

Facility:
Name: North Estonia Medical Centre Foundation ( Site 1601)

Address:
City: Tallin
Zip: 13419
Country: Estonia

Facility:
Name: Tartu University Hospital ( Site 1600)

Address:
City: Tartu
Zip: 50406
Country: Estonia

Facility:
Name: Clinique Clairval ( Site 0802)

Address:
City: Marseille
Zip: 13009
Country: France

Facility:
Name: C.H.R.U. de Brest - Hopital Morvan ( Site 0806)

Address:
City: Brest
Zip: 29200
Country: France

Facility:
Name: Centre Hospitalier Annecy Genevois ( Site 0811)

Address:
City: Epagny Metz Tessy
Zip: 74730
Country: France

Facility:
Name: Clinique Teissier Groupe ( Site 0808)

Address:
City: Valenciennes
Zip: 59304
Country: France

Facility:
Name: Hopital Avicenne ( Site 0803)

Address:
City: Bobigny
Zip: 93000
Country: France

Facility:
Name: Clinique de l'Europe-Service de pneumologie ( Site 0816)

Address:
City: Amiens
Zip: 80000
Country: France

Facility:
Name: H.I.A. Sainte-Anne ( Site 0815)

Address:
City: Toulon
Zip: 83800
Country: France

Facility:
Name: CHD Vendee ( Site 0807)

Address:
City: La Roche sur Yon
Zip: 85925
Country: France

Facility:
Name: Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)

Address:
City: Göttingen
Zip: 37075
Country: Germany

Facility:
Name: Johannes Wesling Klinikum Minden ( Site 0908)

Address:
City: Minden
Zip: 32429
Country: Germany

Facility:
Name: GEHO Muenster ( Site 0910)

Address:
City: Muenster
Zip: 48153
Country: Germany

Facility:
Name: Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)

Address:
City: Neuss
Zip: 41462
Country: Germany

Facility:
Name: LungenClinic Grosshansdorf GmbH ( Site 0901)

Address:
City: Grosshansdorf
Zip: 22927
Country: Germany

Facility:
Name: Zentralklinik Bad Berka GmbH ( Site 0905)

Address:
City: Bad Berka
Zip: 99437
Country: Germany

Facility:
Name: Universitaetsklinikum Jena ( Site 0911)

Address:
City: Jena
Zip: 07747
Country: Germany

Facility:
Name: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)

Address:
City: Berlin
Zip: 13353
Country: Germany

Facility:
Name: Katholisches Marienkrankenhaus gGmbH ( Site 0902)

Address:
City: Hamburg
Zip: 22087
Country: Germany

Facility:
Name: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)

Address:
City: Kecskemét
Zip: 6000
Country: Hungary

Facility:
Name: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)

Address:
City: Gyula
Zip: 5700
Country: Hungary

Facility:
Name: Petz Aladar Megyei Oktato Korhaz ( Site 2306)

Address:
City: Gyor
Zip: 9024
Country: Hungary

Facility:
Name: Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Azienda Ospedaliera Umberto I- Torrette ( Site 1009)

Address:
City: Torrette
Zip: 60126
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Careggi ( Site 1001)

Address:
City: Florence
Zip: 50134
Country: Italy

Facility:
Name: Istituto Clinico Humanitas Research Hospital ( Site 1000)

Address:
City: Rozzano
Zip: 20089
Country: Italy

Facility:
Name: Azienda Ospedaliera Vito Fazzi ( Site 1003)

Address:
City: Lecce
Zip: 73100
Country: Italy

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: Policlinico di Modena ( Site 1007)

Address:
City: Modena
Zip: 41124
Country: Italy

Facility:
Name: Policlinico Agostino Gemelli ( Site 1002)

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)

Address:
City: Udine
Zip: 33100
Country: Italy

Facility:
Name: Kurume University Hospital ( Site 3112)

Address:
City: Kurume
Zip: 830-0011
Country: Japan

Facility:
Name: Kobe Minimally Invasive Cancer Center ( Site 3100)

Address:
City: Kobe
Zip: 650-0046
Country: Japan

Facility:
Name: Kanagawa Cancer Center ( Site 3101)

Address:
City: Yokohama
Zip: 241-8515
Country: Japan

Facility:
Name: Kansai Medical University Hospital ( Site 3103)

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Facility:
Name: Osaka Medical and Pharmaceutical University Hospital ( Site 3110)

Address:
City: Takatsuki
Zip: 5698686
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center ( Site 3104)

Address:
City: Fukuoka
Zip: 811-1395
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital ( Site 3109)

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: Osaka International Cancer Institute ( Site 3106)

Address:
City: Osaka
Zip: 540-0008
Country: Japan

Facility:
Name: Juntendo University Hospital ( Site 3111)

Address:
City: Tokyo
Zip: 113-0033
Country: Japan

Facility:
Name: Tokyo Metropolitan Komagome Hospital ( Site 3108)

Address:
City: Tokyo
Zip: 113-8677
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR ( Site 3107)

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Showa University Hospital ( Site 3105)

Address:
City: Tokyo
Zip: 142-8666
Country: Japan

Facility:
Name: Chungbuk National University Hospital ( Site 2802)

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Facility:
Name: National Cancer Center ( Site 2800)

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea St. Vincent s Hospital ( Site 2805)

Address:
City: Gyeonggi-do
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital ( Site 2801)

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Ajou University Hospital ( Site 2803)

Address:
City: Suwon-si
Zip: 16499
Country: Korea, Republic of

Facility:
Name: Gyeongsang National University Hospital ( Site 2804)

Address:
City: Jinju-si
Zip: 52727
Country: Korea, Republic of

Facility:
Name: Keimyung University Dongsan Hospital ( Site 2807)

Address:
City: Daegu
Zip: 42601
Country: Korea, Republic of

Facility:
Name: Kangbuk Samsung Hospital ( Site 2806)

Address:
City: Seoul
Zip: 03181
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System ( Site 2808)

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Pauls Stradins Clinical University Hospital ( Site 1501)

Address:
City: Riga
Zip: 1002
Country: Latvia

Facility:
Name: Riga East Clinical University Hospital ( Site 1500)

Address:
City: Riga
Zip: 1079
Country: Latvia

Facility:
Name: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)

Address:
City: Kaunas
Zip: 50161
Country: Lithuania

Facility:
Name: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)

Address:
City: Vilnius
Zip: 08660
Country: Lithuania

Facility:
Name: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: CLIMERS Clinical Medical Research ( Site 0506)

Address:
City: Orizaba
Zip: 94300
Country: Mexico

Facility:
Name: Instituto Nacional de Cancerologia ( Site 0502)

Address:
City: Tlalpan
Zip: 14080
Country: Mexico

Facility:
Name: Akershus Universitetssykehus HF ( Site 1106)

Address:
City: Lorenskog
Zip: 1478
Country: Norway

Facility:
Name: Vestre Viken HF Drammen Sykehus ( Site 1101)

Address:
City: Drammen
Zip: 3004
Country: Norway

Facility:
Name: Sykehuset Oestfold ( Site 1107)

Address:
City: Gralum
Zip: 1714
Country: Norway

Facility:
Name: Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)

Address:
City: Stavanger
Zip: 4011
Country: Norway

Facility:
Name: Oslo Universitetssykehus HF. Ulleval ( Site 1100)

Address:
City: Oslo
Zip: 0450
Country: Norway

Facility:
Name: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)

Address:
City: Arequipa
Zip: 04001
Country: Peru

Facility:
Name: Oncosalud ( Site 0605)

Address:
City: Lima
Zip: 15036
Country: Peru

Facility:
Name: Detecta Clínica ( Site 0607)

Address:
City: Surquillo
Zip: 15038
Country: Peru

Facility:
Name: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)

Address:
City: Lima
Zip: 15036
Country: Peru

Facility:
Name: Clinica San Gabriel ( Site 0601)

Address:
City: Lima
Zip: 15088
Country: Peru

Facility:
Name: Hospital Nacional Cayetano Heredia ( Site 0602)

Address:
City: Lima
Zip: 15102
Country: Peru

Facility:
Name: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)

Address:
City: Siedlce
Zip: 08-110
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)

Address:
City: Gdynia
Zip: 81-519
Country: Poland

Facility:
Name: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)

Address:
City: Olsztyn
Zip: 10-228
Country: Poland

Facility:
Name: Spitalul Universitar de Urgenta Bucuresti ( Site 2508)

Address:
City: Bucharest
Zip: 050098
Country: Romania

Facility:
Name: Gral Medical SRL-Medical Oncology ( Site 2511)

Address:
City: București
Zip: 031422
Country: Romania

Facility:
Name: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)

Address:
City: Cluj Napoca
Zip: 400015
Country: Romania

Facility:
Name: S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)

Address:
City: Comuna Floresti
Zip: 407280
Country: Romania

Facility:
Name: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2510)

Address:
City: Craiova
Zip: 200746
Country: Romania

Facility:
Name: Radiology Therapeutic Center-Oncology ( Site 2502)

Address:
City: Otopeni
Zip: 075100
Country: Romania

Facility:
Name: Policlinica Oncomed SRL ( Site 2504)

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)

Address:
City: Timișoara
Zip: 300166
Country: Romania

Facility:
Name: S.C.Focus Lab Plus S.R.L ( Site 2500)

Address:
City: Bucuresti
Zip: 022548
Country: Romania

Facility:
Name: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

Address:
City: Constanta
Zip: 900591
Country: Romania

Facility:
Name: Institutul Regional de Oncologie Iasi ( Site 2505)

Address:
City: Iasi
Zip: 700483
Country: Romania

Facility:
Name: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)

Address:
City: Chelyabinsk
Zip: 454087
Country: Russian Federation

Facility:
Name: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)

Address:
City: Moscow
Zip: 125284
Country: Russian Federation

Facility:
Name: Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)

Address:
City: Nizhniy Novgorod
Zip: 603081
Country: Russian Federation

Facility:
Name: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)

Address:
City: Saint-Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Medical institute named after Berezin Sergey ( Site 1906)

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Sverdlovsk Regional Oncology Hospital ( Site 1909)

Address:
City: Ekaterinburg
Zip: 620036
Country: Russian Federation

Facility:
Name: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)

Address:
City: Kazan
Zip: 420029
Country: Russian Federation

Facility:
Name: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)

Address:
City: Yaroslavl
Zip: 150054
Country: Russian Federation

Facility:
Name: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Hospital Universitario Quiron Madrid ( Site 1200)

Address:
City: Pozuelo de Alarcon
Zip: 28223
Country: Spain

Facility:
Name: H.R.U Málaga - Hospital General ( Site 1206)

Address:
City: Málaga
Zip: 29011
Country: Spain

Facility:
Name: H.U. Vall de Hebron ( Site 1201)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Clinic de Barcelona ( Site 1204)

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital Universitario Virgen Macarena ( Site 1205)

Address:
City: Sevilla
Zip: 41009
Country: Spain

Facility:
Name: Hospital Universitario La Fe ( Site 1203)

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Chulalongkorn University ( Site 3003)

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Facility:
Name: Ramathibodi Hospital. ( Site 3000)

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Facility:
Name: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)

Address:
City: Chiang Mai
Zip: 50200
Country: Thailand

Facility:
Name: Srinagarind Hospital. Khon Kaen University ( Site 3002)

Address:
City: Khon Kaen
Zip: 40002
Country: Thailand

Facility:
Name: Ankara Bilkent Sehir Hastanesi ( Site 2002)

Address:
City: Ankara
Zip: 06800
Country: Turkey

Facility:
Name: Memorial Ankara Hastanesi ( Site 2006)

Address:
City: Ankara
Zip: 06520
Country: Turkey

Facility:
Name: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)

Address:
City: Istanbul
Zip: 34098
Country: Turkey

Facility:
Name: Medipol Universite Hastanesi ( Site 2003)

Address:
City: Istanbul
Zip: 34214
Country: Turkey

Facility:
Name: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Facility:
Name: Ege University Medical Faculty ( Site 2005)

Address:
City: Izmir
Zip: 35100
Country: Turkey

Facility:
Name: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

Address:
City: Dnipro
Zip: 49055
Country: Ukraine

Facility:
Name: SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (

Address:
City: Kharkiv
Zip: 61024
Country: Ukraine

Facility:
Name: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

Address:
City: Antonivka Village
Zip: 73000
Country: Ukraine

Facility:
Name: LLC Ukrainian Center of Tomotherapy ( Site 2105)

Address:
City: Kropyvnytskyi
Zip: 25011
Country: Ukraine

Facility:
Name: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

Address:
City: Kapitanivka Village
Zip: 08111
Country: Ukraine

Facility:
Name: SNPE National Cancer Institute ( Site 2101)

Address:
City: Kyiv
Zip: 03022
Country: Ukraine

Facility:
Name: Medical Center Verum ( Site 2106)

Address:
City: Kyiv
Zip: 03039
Country: Ukraine

Facility:
Name: Kyiv City Clinical Oncology Center ( Site 2100)

Address:
City: Kyiv
Zip: 03115
Country: Ukraine

Facility:
Name: Weston Park Hospital ( Site 1406)

Address:
City: Sheffield
Zip: S10 2SJ
Country: United Kingdom

Facility:
Name: University College Hospital NHS Foundation Trust ( Site 1403)

Address:
City: London-Camden
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Guys and St Thomas NHS Foundation Trust ( Site 1410)

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: Royal Marsden Hospital (Sutton) ( Site 1407)

Address:
City: London
Zip: SM2 5PT
Country: United Kingdom

Facility:
Name: Southampton General Hospital ( Site 1400)

Address:
City: Southampton
Zip: SO16 6YD
Country: United Kingdom

Facility:
Name: Leeds Teaching Hospitals NHS Trust ( Site 1401)

Address:
City: Leeds
Zip: LS9 7TF
Country: United Kingdom

Facility:
Name: Christie NHS Foundation Trust ( Site 1409)

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Start date: July 6, 2020

Completion date: February 15, 2027

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04380636
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7339-012&kw=7339-012