Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
研究单位：[1]Merck Sharp & Dohme LLC[2]Mid Florida Hematology and Oncology Center ( Site 0005),Orange City,Florida,United States,32763[3]Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003),Marietta,Georgia,United States,30060[4]Karmanos Cancer Institute ( Site 0018),Detroit,Michigan,United States,48201[5]Hattiesburg Clinic Hematology/Oncology ( Site 0010),Hattiesburg,Mississippi,United States,39401[6]University Of Nebraska Medical Center ( Site 0011),Omaha,Nebraska,United States,68198[7]Capital Health Medical Center - Hopewell ( Site 0006),Pennington,New Jersey,United States,08534[8]University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015),Cincinnati,Ohio,United States,45219[9]St. George Private Hospital ( Site 3004),Kogarah,New South Wales,Australia,2217[10]Westmead Hospital-Department of Medical Oncology ( Site 3000),Westmead,New South Wales,Australia,2145[11]Monash Health-Oncology Research ( Site 3001),Clayton,Victoria,Australia,3168[12]Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003),Melbourne,Victoria,Australia,3021[13]Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447),Natal,Rio Grande Do Norte,Brazil,59075-740[14]Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440),Porto Alegre,Rio Grande Do Sul,Brazil,91350-200[15]Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444),Barretos,Sao Paulo,Brazil,14784-400[16]Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446),São Paulo,Sao Paulo,Brazil,04014-002[17]Hospital Paulistano-Americas Oncologia ( Site 0441),Sao Paulo,Brazil,01321-001[18]A. C. Camargo Cancer Center-CAPEC ( Site 0442),Sao Paulo,Brazil,01509-010[19]William Osler Health System ( Site 0205),Brampton,Ontario,Canada,L6R 3J7[20]Princess Margaret Cancer Centre ( Site 0204),Toronto,Ontario,Canada,M5G 2M9[21]Centro Investigacion Cancer James Lind ( Site 0513),Temuco,Araucania,Chile,4780000[22]Clinica Universidad Catolica del Maule-Oncology ( Site 0501),Talca,Maule,Chile,3465584[23]Orlandi Oncologia-Oncology ( Site 0504),Santiago,Region M. De Santiago,Chile,7500713[24]FALP-UIDO ( Site 0509),Santiago,Region M. De Santiago,Chile,7500921[25]Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0502),Santiago,Region M. De Santiago,Chile,8330032[26]Bradfordhill-Clinical Area ( Site 0507),Santiago,Region M. De Santiago,Chile,8420383[27]ONCOCENTRO APYS-ACEREY ( Site 0500),Viña del Mar,Valparaiso,Chile,2520598[28]Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810),Beijing,Beijing,China,100142[29]Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815),Beijing,Beijing,China,100730[30]Chongqing University Cancer Hospital-Medical Oncology ( Site 2814),Chongqing,Chongqing,China,400030[31]Fujian Cancer Hospital ( Site 2819),Fuzhou,Fujian,China,350014[32]The First Affiliated hospital of Xiamen University ( Site 2820),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 Cancer Hospital-Respiratory Oncology ( Site 2816),Nanning,Guangxi,China,530201[35]Harbin Medical University Cancer Hospital-oncology of department ( Site 2807),Harbin,Heilongjiang,China,150081[36]Henan Cancer Hospital-henan cancer hospital ( Site 2813),Zhengzhou,Henan,China,450000[37]Tongji Hospital Tongji Medical,Science & Technology ( Site 2805),Wuhan,Hubei,China,430000[38]Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806),Wuhan,Hubei,China,430022[39]Hubei Cancer Hospital ( Site 2809),Wuhan,Hubei,China,430079[40]The Second Xiangya Hospital of Central South University ( Site 2827),Changsha,Hunan,China,410011[41]Hunan Cancer Hospital-thoracic oncology II ( Site 2808),Changsha,Hunan,China,410013[42]Nanjing Drum Tower Hospital ( Site 2812),Nangjing,Jiangsu,China,210008[43]The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821),Nanchang,Jiangxi,China,330006[44]The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817),Xi'an,Shaanxi,China,710061[45]Jinan Central Hospital-oncology department ( Site 2802),Jinan,Shandong,China,250013[46]LinYi Cancer Hospital ( Site 2804),Linyi,Shandong,China,276001[47]Shanghai Chest Hospital-Oncology department ( Site 2800),Shanghai,Shanghai,China,200030[48]Fudan University Shanghai Cancer Center-Oncology ( Site 2811),Shanghai,Shanghai,China,200032[49]Sichuan Cancer hospital ( Site 2822),Chengdu,Sichuan,China,610042[50]Yunnan Province Cancer Hospital ( Site 2824),Kunming,Yunnan,China,650118[51]Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828),Hangzhou,Zhejiang,China,310016[52]Klinikum Chemnitz - Flemmingstraße ( Site 1401),Chemnitz,Sachsen,Germany,09116[53]Hong Kong Integrated Oncology Centre ( Site 3200),Central,Hong Kong,0000[54]Queen Mary Hospital ( Site 3203),Hksar,Hong Kong[55]Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204),Kowloon,Hong Kong,999077[56]Princess Margaret Hospital-Department of Oncology ( Site 3201),Lai Chi Kok,Hong Kong,55555[57]Rambam Health Care Campus-Oncology Division ( Site 1702),Haifa,Israel,3109601[58]Shaare Zedek Medical Center ( Site 1700),Jerusalem,Israel,9103102[59]Rabin Medical Center ( Site 1703),Petah Tikva,Israel,4941 492[60]Aichi Cancer Center Hospital ( Site 3400),Nagoya,Aichi,Japan,464-8681[61]Gunma Prefectural Cancer Center ( Site 3418),Otashi,Gunma,Japan,373-8550[62]Takarazuka City Hospital ( Site 3409),Takarazuka,Hyogo,Japan,665-0827[63]Kanagawa cancer center-Department of Thoracic Oncology ( Site 3404),Yokohama,Kanagawa,Japan,241-8515
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
