Clinical trial NCT06345729: A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)
Official title: A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:

Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).


Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of NSCLC
* Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
* Has measurable disease based on RECIST 1.1
* Has provided tumor tissue that demonstrates PD-L1 expression in ≥50% of tumor cells
* Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
* Has life expectancy of at least 3 months
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 10 days after the last dose of oral intervention: Either be abstinent or must agree to use male condom plus additional contraceptive method.
* For participant assigned female sex at birth: Either be a person of nonchildbearing potential (PONCBP) or must agree to follow contraceptive guidance during the study treatment period and for at least 10 days after the last dose of oral intervention and 120 days after the last dose of pembrolizumab. Must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization

Exclusion Criteria:

* Diagnosis of small cell lung cancer
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
* Has one or more of the following ophthalmological findings/conditions: intraocular diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease pressure \>21 mm Hg and/or any diagnosis of glaucoma
* Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption)
* Received prior systemic anticancer therapy for their metastatic NSCLC
* Received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor within 12 months before diagnosis of metastatic NSCLC
* Has received radiotherapy within 2 weeks of start of study intervention
* 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 an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* History of allogeneic tissue/solid organ transplant
* Has not fully recovered from any effects of major surgical procedure. Surgical procedures that required general anesthesia must be completed at least 2 weeks before first study intervention administration.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 42 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 56 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 42 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 42 months
measure: Number of Participants Who Experience One or More Adverse Event (AEs)
timeFrame: Up to approximately 56 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 56 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
timeFrame: Baseline and Up to approximately 24 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
timeFrame: Baseline and Up to approximately 24 months
measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score
timeFrame: Baseline and Up to approximately 24 months
measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score
timeFrame: Baseline and Up to approximately 24 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. ( Site 0123)
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center ( Site 0116)
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 0137)
state: Florida
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc. ( Site 0115)
state: Illinois
city: Kansas City
country: United States
facility: Truman Medical Center ( Site 0126)
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center North ( Site 0133)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center-Research ( Site 0105)
state: Montana
city: Morristown
country: United States
facility: Atlantic Health System Morristown Medical Center ( Site 0121)
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C. ( Site 0132)
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
state: Ohio
city: Kettering
country: United States
facility: Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
state: Ohio
city: Houston
country: United States
facility: Oncology Consultants P.A. ( Site 0113)
state: Texas
city: Madison
country: United States
facility: Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
state: Wisconsin
city: Caba
country: Argentina
facility: AUSTRAL MEDICAL CENTER ( Site 0302)
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Oncologico Korben ( Site 0304)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos ( Site 0306)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0301)
state: Santa Fe
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse ( Site 3000)
state: New South Wales
city: Frankston
country: Australia
facility: Frankston Hospital ( Site 3002)
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research ( Site 3001)
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)
state: Steiermark
city: Wien
country: Austria
facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)
city: Belo Horizonte
country: Brazil
facility: Hospital Mario Penna ( Site 0436)
state: Minas Gerais
city: Recife
country: Brazil
facility: Hospital de Câncer de Recife ( Site 0447)
state: Pernambuco
city: Terezina
country: Brazil
facility: Oncoclínica Oncologistas Associados ( Site 0441)
state: Piaui
city: Natal.
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer ( Site 0439)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)
state: Rio Grande Do Sul
city: Barretos.
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA ( Site 0446)
city: Rio de Janeiro
country: Brazil
facility: Americas ( Site 0431)
city: Panagyurishte
country: Bulgaria
facility: MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)
state: Pazardzhik
city: Pleven
country: Bulgaria
facility: MHAT - Heart and Brain ( Site 1006)
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0210)
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0206)
state: Ontario
city: Montreal
country: Canada
facility: St. Marys Hospital Center ( Site 0204)
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)
state: Quebec
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
state: Maule
city: Santiago
country: Chile
facility: Orlandi Oncologia-Oncology ( Site 0503)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0501)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Oncología de Precisión-Oncology ( Site 0502)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0504)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 3136)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital ( Site 3133)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital ( Site 3134)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital,Capital Medical University ( Site 3104)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 3119)
state: Chongqing
city: Chongqing
country: China
facility: Army Medical Center of People's Liberation Army ( Site 3142)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital ( Site 3127)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University ( Site 3148)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 3128)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center ( Site 3137)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 3123)
state: Heilongjiang
city: Jiamusi
country: China
facility: JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 3149)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 3126)
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 3130)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 3141)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Gulou Hospital ( Site 3122)
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital ( Site 3154)
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University ( Site 3146)
state: Jiangsu
city: Wuxi City
country: China
facility: Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University ( Site 3139)
state: Jiangxi
city: Nanchang
country: China
facility: The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital ( Site 3107)
state: Jilin
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 3116)
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital ( Site 3111)
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital ( Site 3100)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 3144)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University ( Site 3143)
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital ( Site 3131)
state: Shanxi
city: Xian
country: China
facility: The Second Affiliated Hospital of Air Force Medical University ( Site 3117)
state: Shanxi
city: Xian
country: China
facility: The Second Affiliated Hospital of Air Force Medical University ( Site 3152)
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University ( Site 3140)
state: Sichuan
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 3109)
state: Sichuan
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang ( Site 3105)
state: Sichuan
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 3153)
state: Yunnan
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province ( Site 3145)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
state: Zhejiang
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1103)
state: Bourgogne
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré-Department of Respiratory Diseases and Thoracic Oncology ( Site 1105)
state: Ile-de-France
city: Valenciennes
country: France
facility: Clinique Teissier Groupe ( Site 1100)
state: Nord
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1101)
state: Puy-de-Dome
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1104)
state: Vaucluse
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter ( Site 1203)
state: Ajaria
city: Tbilisi
country: Georgia
facility: American Hospital Network LLC ( Site 1208)
city: Tbilisi
country: Georgia
facility: Todua Clinic, LLC ( Site 1204)
city: Tbilisi
country: Georgia
facility: TSMU and Ingorokva High Medical Technology University Clinic LTD ( Site 1201)
city: Tbilisi
country: Georgia
facility: New Hospitals ( Site 1200)
city: Tbilisi
country: Georgia
facility: Cancer Research Centre. Mardaleishvili Medical Centre ( Site 1205)
city: Tbilisi
country: Georgia
facility: Caucasus Medical Centre ( Site 1202)
city: Tbilisi
country: Georgia
facility: Tbilisi Institute of Medicine ( Site 1206)
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart ( Site 1302)
state: Baden-Wurttemberg
city: Solingen
country: Germany
facility: Krankenhaus Bethanien ( Site 1303)
state: Nordrhein-Westfalen
city: Patras
country: Greece
facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1402)
state: Achaia
city: Athens
country: Greece
facility: THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1400)
state: Attiki
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic ( Site 1404)
state: Kentriki Makedonia
city: Larissa
country: Greece
facility: University General Hospital of Larissa-Oncology Clinic ( Site 1403)
state: Thessalia
city: Thessaloniki
country: Greece
facility: G. Papanikolaou General Hospital-Pulmonary Clinic of Aristotle University of Thessaloniki ( Site 1405)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1607)
state: Campania
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci ( Site 1606)
state: Emilia-Romagna
city: Aviano
country: Italy
facility: CRO-IRCCS-Clinical Oncology ( Site 1605)
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1601)
state: Lazio
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1604)
state: Lombardia
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1609)
state: Roma
city: Livorno
country: Italy
facility: Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno-UOC Oncologia Medica Livorno ( Site 1608)
state: Toscana
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 3309)
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 3310)
state: Aichi
city: Matsuyam
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 3315)
state: Ehime
city: Fukuoka,
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 3316)
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 3317)
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 3302)
state: Gunma
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 3308)
state: Ishikawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 3320)
state: Kanagawa
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital ( Site 3311)
state: Mie
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 3301)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 3300)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 3312)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3313)
state: Osaka
city: Bunkyo
country: Japan
facility: Nippon Medical School Hospital ( Site 3306)
state: Tokyo
city: Ota
country: Japan
facility: Toho University Omori Medical Center ( Site 3319)
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital ( Site 3307)
state: Tokyo
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine ( Site 3305)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 3322)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 3314)
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital ( Site 3318)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 3321)
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)
state: Incheon
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)
state: Jeonranamdo
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)
state: Kyonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)
state: Kyongsangnam-do
city: Jung-gu
country: Korea, Republic of
facility: Chungnam national university hospital ( Site 3602)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital ( Site 3605)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 3601)
city: Mexico
country: Mexico
facility: Arké SMO S.A. de C.V. ( Site 0602)
state: Distrito Federal
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 0603)
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal-Poli Longziekten ( Site 1701)
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle-Poli Longziekten ( Site 1700)
state: Overijssel
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht ( Site 1704)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 3400)
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines-Pulmonary, Critical Care and Sleep Medicine ( Site 3503)
state: National Capital Region
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Center-Section of Oncology ( Site 3505)
state: National Capital Region
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1994)
state: Dolj
city: Timișoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 1998)
state: Timis
city: Brasov
country: Romania
facility: SC ONCO CARD SRL ( Site 1995)
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj-Oncologie Medicala ( Site 1999)
city: Suceava
country: Romania
facility: Sigmedical Services SRL ( Site 1997)
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 2019)
state: Las Palmas
city: Madrid
country: Spain
facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2012)
state: Madrid, Comunidad De
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General-Oncology ( Site 2014)
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 2010)
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2017)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2015)
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2107)
city: Ankara
country: Turkey
facility: SBU GULHANE EGITIM VE ARASTIRMA HASTANESI Onkoloji ( Site 2104)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2101)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)
city: Istanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 2105)
city: Cherkasy
country: Ukraine
facility: COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)
state: Cherkaska Oblast
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Bukovinian Clinica-structural unit of the clinical trials ( Site 2210)
state: Chernivetska Oblast
city: Kryvyi Rih
country: Ukraine
facility: Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2215)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 2202)
state: Ivano-Frankivska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)
state: Kirovohradska Oblast
city: Kiev
country: Ukraine
facility: Medical Center "MedOffice Group" ( Site 2219)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital ( Site 2217)
state: Lvivska Oblast
city: Rivne
country: Ukraine
facility: Rivne Regional Clinical Hospital ( Site 2205)
state: Rivnenska Oblast
city: Vinnytsia
country: Ukraine
facility: Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)
state: Vinnytska Oblast
city: Lutsk
country: Ukraine
facility: ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)
state: Volynska Oblast
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: