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Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

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研究单位: [1]Merck Sharp & Dohme LLC [2]Gilead Sciences [3]Infirmary Cancer Care ( Site 0418),Mobile,Alabama,United States,36607 [4]Clermont Oncology Center ( Site 0421),Clermont,Florida,United States,34711 [5]Mid Florida Hematology and Oncology Center ( Site 0416),Orange City,Florida,United States,32763 [6]Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407),Marietta,Georgia,United States,30060 [7]Our Lady of the Lake RMC ( Site 0424),Baton Rouge,Louisiana,United States,70808 [8]White Plains Hospital-Center for Cancer Care ( Site 0403),White Plains,New York,United States,10601 [9]Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408),Portland,Oregon,United States,97227 [10]Central Texas Veterans health care ( Site 0414),Temple,Texas,United States,76504 [11]Orange Hospital-Clinical Trials Unit ( Site 0600),Orange,New South Wales,Australia,2800 [12]Cancer Research SA-St Andrews Hospital ( Site 0603),Adelaide,South Australia,Australia,5000 [13]Frankston Hospital-Oncology and Haematology ( Site 0601),Frankston,Victoria,Australia,3199 [14]CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320),Fortaleza,Ceara,Brazil,60336232 [15]Hospital Tacchini ( Site 0322),Bento Goncalves,Rio Grande Do Sul,Brazil,95700-068 [16]Hospital da Cidade de Passo Fundo ( Site 0321),Passo Fundo,Rio Grande Do Sul,Brazil,99010-260 [17]Instituto de Oncologia Saint Gallen ( Site 0317),Santa Cruz do Sul,Rio Grande Do Sul,Brazil,96830-180 [18]Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318),Barretos,Sao Paulo,Brazil,14784400 [19]A. C. Camargo Cancer Center ( Site 0324),Sao Paulo,Brazil,01509-010 [20]Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430),Greenfield Park,Quebec,Canada,J4V 2H1 [21]St. Marys Hospital Center-Oncology ( Site 0434),Montreal,Quebec,Canada,H3T 1M5 [22]Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431),Trois-Rivières,Quebec,Canada,G8Z 3R9 [23]Oncovida ( Site 0334),Santiago,Region M. De Santiago,Chile,7510032 [24]Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0332),Santiago,Region M. De Santiago,Chile,8330032 [25]Anhui Provincial Hospital ( Site 0136),Hefei,Anhui,China,230071 [26]Second Affiliated hospital of Anhui Medical University ( Site 0126),Hefei,Anhui,China,230601 [27]Beijing Cancer hospital ( Site 0104),Beijing,Beijing,China,100142 [28]Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106),Beijing,Beijing,China,100730 [29]Beijing Chest Hospital,Capital Medical University ( Site 0105),Beijing,Beijing,China,101149 [30]Chongqing University Cancer Hospital-Medical Oncology ( Site 0130),Chongqing,Chongqing,China,400030 [31]Fujian Provincial Cancer Hospital ( Site 0131),Fuzhou,Fujian,China,350014 [32]The First Affiliated hospital of Xiamen University ( Site 0132),Xiamen,Fujian,China,361003 [33]Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (,Guangzhou,Guangdong,China,510515 [34]Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 0113),Nanning,Guangxi,China,530021 [35]Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115),Wuhan,Hubei,China,430022 [36]Tongji Hospital Tongji Medical,Science & Technology ( Site 0116),Wuhan,Hubei,China,430030 [37]Hubei Cancer Hospital ( Site 0107),Wuhan,Hubei,China,430079 [38]The Second Xiangya Hospital of Central South University ( Site 0135),Changsha,Hunan,China,410011 [39]Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112,Nanjing,Jiangsu,China,210000 [40]The First Affliated Hospital of Suzhou University ( Site 0114),Suzhou,Jiangsu,China,215000 [41]The Second Affiliated Hospital of Nanchang University ( Site 0134),Nanchang,Jiangxi,China,330006 [42]The First Hospital of Jilin University ( Site 0117),Changchun,Jilin,Chin

关键词: Programmed Cell Death-1 (PD1 PD-1) Programmed Death-Ligand 1 (PDL1 PD-L1) Programmed Cell Death-2 (PD2 PD-2) Programmed Death-Ligand 2 (PDL2 PD-L2) Trophoblast Cell Surface Antigen-2 (TROP-2) Antibody-Drug Conjugate (ADC)

研究目的:
The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

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