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)
研究单位：[1]Merck Sharp & Dohme LLC[2]Beverly Hills Cancer Center ( Site 0116),Beverly Hills,California,United States,90211[3]St. Vincent Frontier Cancer Center-Research ( Site 0105),Billings,Montana,United States,59102[4]University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103),Cincinnati,Ohio,United States,45219[5]Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106),Kettering,Ohio,United States,45429[6]Oncology Consultants P.A. ( Site 0113),Houston,Texas,United States,77030[7]AUSTRAL MEDICAL CENTER ( Site 0302),Caba,Buenos Aires,Argentina,C1019ABS[8]Centro Oncologico Korben ( Site 0304),Caba,Buenos Aires,Argentina,C1426AGE[9]Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300),Mar del Plata,Buenos Aires,Argentina,B7600FZO[10]Sanatorio Parque ( Site 0301),Rosario,Santa Fe,Argentina,S2000DSV[11]Frankston Hospital ( Site 3002),Frankston,Victoria,Australia,3199[12]One Clinical Research ( Site 3001),Nedlands,Western Australia,Australia,6009[13]Hospital de Câncer de Recife ( Site 0447),Recife,Pernambuco,Brazil,50040-000[14]Oncoclínica Oncologistas Associados ( Site 0441),Terezina,Piaui,Brazil,64049-200[15]Liga Norte Riograndense Contra o Câncer ( Site 0439),Natal,Rio Grande Do Norte,Brazil,59062-000[16]Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica,Porto Alegre,Rio Grande Do Sul,Brazil,90050-170[17]Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437),Barretos,Sao Paulo,Brazil,14784-400[18]Americas ( Site 0431),Rio de Janeiro,Brazil,22775-001[19]Clinica Universidad Catolica del Maule-Oncology ( Site 0500),Talca,Maule,Chile,3465584[20]Orlandi Oncologia-Oncology ( Site 0503),Santiago,Region M. De Santiago,Chile,7500713[21]FALP-UIDO ( Site 0501),Santiago,Region M. De Santiago,Chile,7500921[22]Centro de Oncología de Precisión-Oncology ( Site 0502),Santiago,Region M. De Santiago,Chile,7560908[23]Bradfordhill-Clinical Area ( Site 0504),Santiago,Region M. De Santiago,Chile,8420383[24]Anhui Provincial Cancer Hospital ( Site 3136),Hefei,Anhui,China,230000[25]Beijing Cancer hospital ( Site 3133),Beijing,Beijing,China,100142[26]Beijing Cancer hospital ( Site 3134),Beijing,Beijing,China,100142[27]Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102),Beijing,Beijing,China,100730[28]Beijing Chest Hospital,Capital Medical University ( Site 3104),Beijing,Beijing,China,101149[29]Chongqing University Cancer Hospital ( Site 3119),Chongqing,Chongqing,China,400030[30]The First Affiliated Hospital of Guangzhou Medical University ( Site 3108),Guangzhou,Guangdong,China,510160[31]Southern Medical University Nanfang Hospital ( Site 3128),Guangzhou,Guangdong,China,510515[32]Sun Yat-sen University Cancer Center ( Site 3137),Guangzhou,Guangdong,China,510555[33]JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124),Jiamusi,Heilongjiang,China,154007[34]Tongji Hospital Tongji Medical,Science & Technology ( Site 3113),Wuhan,Hubei,China,430000[35]Hubei Cancer Hospital ( Site 3126),Wuhan,Hubei,China,430079[36]Hunan Cancer Hospital ( Site 3141),Changsha,Hunan,China,410013[37]Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3122,NanJing,Jiangsu,China,210008[38]Nanjing First Hospital ( Site 3154),Nanjing,Jiangsu,China,210012[39]The First Affiliated Hospital of Soochow University ( Site 3146),Suzhou,Jiangsu,China,215006[40]Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155),Wuxi City,Jiangsu,China,214122[41]The Second Affiliated Hospital of Nanchang University ( Site 3139),Nanchang,Jiangxi,China,330000[42]The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138),Nanchang,Jiangxi,China,330209[43]Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 311,Xi'an,Shaanxi,China,710038[44]Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 315,Xi'an,Shaanxi,China,710038[45]The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150),Xi'an,Shaanxi,China,710061[46]LinYi Cancer Hospital ( Site 3111),Linyi,Shandong,China,276001[47]Shanghai Chest Hospital ( Site 3100),Shanghai,Shanghai,China,200030[48]Zhongshan Hospital,Fudan University ( Site 3143),Shanghai,Shanghai,China,200032[49]West China Hospital, Sichuan University ( Site 3140),Cheng Du,Sichuan,China,610041[50]The Third People's Hospital of Chengdu (CDTPH) ( Site 3157),Chengdu,Sichuan,China,610031[51]Sichuan Cancer hospital. ( Site 3109),Chengdu,Sichuan,China,610042[52]The Second People's Hospital of Neijiang ( Site 3105),Neijiang,Sichuan,China,641000[53]Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3121),Hangzhou,Zhejiang,China,310016[54]Taizhou Hospital of Zhejiang Province ( Site 3145),Linhai,Zhejiang,China,317000[55]The First Affiliated Hospital of Wenzhou Medical University ( Site 3151),Wenzhou,Zhejiang,China,325015[56]National Hospital Organization Kyushu Cancer Center ( Site 3316),Fukuoka,,Fukuoka,Japan,811-1395[57]Matsusaka Municipal Hospital ( Site 3311),Matsusaka,Mie,Japan,515-8544[58]Miyagi Cancer Center ( Site 3301),Natori,Miyagi,Japan,981-1293[59]Osaka Medical and Pharmaceutical University Hospital ( Site 3313),Takatsuki,Osaka,Japan,569-8686[60]Nippon Medical School Hospital ( Site 3306),Bunkyo,Tokyo,Japan,113-8603[61]Center Hospital of the National Center for Global Health and Medicine ( Site 3305),Shinjuku,Tokyo,Japan,162-8655[62]Saiseikai Kumamoto Hospital ( Site 3318),Kumamoto,Japan,861-4193[63]The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606),Bupyeong-gu,Incheon,Korea, Republic of,21431
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).
