Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
研究单位：[1]Merck Sharp & Dohme LLC[2]Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130),Burbank,California,United States,91505[3]Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106),Marietta,Georgia,United States,30060[4]The University of Louisville, James Graham Brown Cancer Center ( Site 0121),Louisville,Kentucky,United States,40245[5]New England Cancer Specialists ( Site 0143),Scarborough,Maine,United States,04074[6]University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144),Worcester,Massachusetts,United States,01655[7]Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115),Minneapolis,Minnesota,United States,55407[8]Hattiesburg Clinic Hematology/Oncology ( Site 0104),Hattiesburg,Mississippi,United States,39401[9]Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134),Reno,Nevada,United States,89502[10]University Hospitals Cleveland Medical Center ( Site 0119),Cleveland,Ohio,United States,44106[11]Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117),Corvallis,Oregon,United States,97330[12]Oncology Consultants P.A. ( Site 0129),Houston,Texas,United States,77030[13]Instituto Alexander Fleming ( Site 0306),Ciudad Autónoma de Buenos Aires,Buenos Aires,Argentina,C1426ANZ[14]Hospital Británico de Buenos Aires-Oncology ( Site 0304),Ciudad autónoma de Buenos Aires,Caba,Argentina,C1280AEB[15]Centro Privado de RMI Río Cuarto S.A. II ( Site 0310),Río Cuarto,Cordoba,Argentina,X5800ALB[16]Instituto de Oncología de Rosario ( Site 0301),Rosario,Santa Fe,Argentina,S2000KZE[17]Hospital Aleman-Oncology ( Site 0300),Buenos Aires,Argentina,C1118AAT[18]Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002),Port Macquarie,New South Wales,Australia,2444[19]Westmead Hospital-Department of Medical Oncology ( Site 3000),Westmead,New South Wales,Australia,2145[20]Grampians Health-Medical Oncology ( Site 3001),Ballarat Central,Victoria,Australia,3350[21]Northern Hospital ( Site 3003),Epping,Victoria,Australia,3076[22]Clinica Viver ( Site 0400),Santa Maria,Rio Grande Do Sul,Brazil,97015-450[23]Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401),São Paulo,Sao Paulo,Brazil,04014-002[24]McGill University Health Centre ( Site 0200),Montréal,Quebec,Canada,H4A 3J1[25]Clinica Universidad Catolica del Maule-Oncology ( Site 0501),Talca,Maule,Chile,3465584[26]Orlandi Oncologia-Oncology ( Site 0504),Santiago,Region M. De Santiago,Chile,7500713[27]FALP-UIDO ( Site 0509),Santiago,Region M. De Santiago,Chile,7500921[28]Bradfordhill-Clinical Area ( Site 0507),Santiago,Region M. De Santiago,Chile,8420383[29]Second Affiliated hospital of Anhui Medical University ( Site 3133),Hefei,Anhui,China,230000[30]Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101),Beijing,Beijing,China,100142[31]Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100),Beijing,Beijing,China,100730[32]Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 3131),Fuzhou,Fujian,China,350014[33]The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107),Xiamen,Fujian,China,361003[34]The First Affiliated Hospital of Guangzhou Medical University ( Site 3134),Guangzhou,Guangdong,China,510160[35]Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (,Guangzhou,Guangdong,China,510515[36]Affiliated Hospital of Guangdong Medical University ( Site 3123),Zhanjiang,Guangdong,China,524004[37]The Second Hospital of Hebei Medical University ( Site 3135),Shijiazhuang,Hebei,China,050000[38]Tongji Hospital Tongji Medical,Science & Technology ( Site 3117),Wuhan,Hubei,China,430000[39]Wuhan Union Hospital Cancer Center-Cancer center ( Site 3130),Wuhan,Hubei,China,430022[40]Hubei Cancer Hospital ( Site 3106),Wuhan,Hubei,China,430079[41]Xiangyang Central Hospital-oncology department ( Site 3136),Xiangyang,Hubei,China,441021[42]The Second Xiangya Hospital of Central South University-Oncology ( Site 3138),Changsha,Hunan,China,410011[43]Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113),Wuxi,Jiangsu,China,214122[44]The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127),Nanchang,Jiangxi,China,330006[45]The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121),Nanchang,Jiangxi,China,330006[46]Jiangxi Provincial Cancer Hospital ( Site 3143),Nanchang,Jiangxi,China,330029[47]Jinan Central Hospital-oncology department ( Site 3122),Jinan,Shandong,China,250013[48]Shandong Cancer Hospital-Respiratory Department ( Site 3119),Jinan,Shandong,China,250117[49]Shanghai Changhai Hospital ( Site 3125),Shanghai,Shanghai,China,200082[50]Sichuan Cancer hospital ( Site 3105),Chengdu,Sichuan,China,610042[51]The Second People's Hospital of Neijiang ( Site 3140),Neijiang,Sichuan,China,641000[52]Yunnan Province Cancer Hospital ( Site 3139),Kunming,Yunnan,China,650118[53]The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115),Hangzhou,Zhejiang,China,310003[54]Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111),Hangzhou,Zhejiang,China,310016[55]Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114),Taizhou,Zhejiang,China,317000[56]Oncomedica S.A.S ( Site 0602),Montería,Cordoba,Colombia,230002[57]FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit,Bogota,Distrito Capital De Bogota,Colombia,110131[58]Oncologos del Occidente ( Site 0603),Pereira,Risaralda,Colombia,660001[59]Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103),Ostrava,Ostrava Mesto,Czechia,703 00
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
