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A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

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研究单位: [1]Merck Sharp & Dohme LLC [2]Mount Sinai Cancer Center ( Site 0038),Miami Beach,Florida,United States,33140 [3]Mid Florida Hematology and Oncology Center ( Site 0018),Orange City,Florida,United States,32763 [4]Centricity Research Columbus Cancer Center ( Site 0005),Columbus,Georgia,United States,31904 [5]Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017),Elmhurst,Illinois,United States,60126 [6]Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078),Naperville,Illinois,United States,60540 [7]Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027),Minneapolis,Minnesota,United States,55407 [8]Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037),Reno,Nevada,United States,89502 [9]Millennium Research & Clinical Development ( Site 0039),Houston,Texas,United States,77090 [10]Westmead Hospital-Department of Medical Oncology ( Site 0701),Westmead,New South Wales,Australia,2145 [11]The Prince Charles Hospital ( Site 0700),Brisbane,Queensland,Australia,4032 [12]Fiona Stanley Hospital-Medical Oncology ( Site 0705),Murdoch,Western Australia,Australia,6150 [13]Liga Norte Riograndense Contra o Câncer ( Site 0301),Natal,Rio Grande Do Norte,Brazil,59062-000 [14]Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303),Porto Alegre,Rio Grande Do Sul,Brazil,90020-090 [15]Instituto de Oncologia Saint Gallen ( Site 0319),Santa Cruz do Sul,Rio Grande Do Sul,Brazil,96830-180 [16]Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304),Barretos,Sao Paulo,Brazil,14784400 [17]FALP-UIDO ( Site 0401),Providencia,Region M. De Santiago,Chile,7500921 [18]Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404),Santiago,Region M. De Santiago,Chile,7501010 [19]ONCOCENTRO APYS-ACEREY ( Site 0410),Viña del Mar,Valparaiso,Chile,2520598 [20]Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301),Beijing,Beijing,China,100010 [21]Peking University People's Hospital. ( Site 1300),Beijing,Beijing,China,100034 [22]The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 132,Guangzhou,Guangdong,China,510120 [23]Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313),Guangzhou,Guangdong,China,510515 [24]Nanjing First Hospital ( Site 1310),Nanjing,Jiangsu,China,210012 [25]The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330),Nanchang,Jiangxi,China,330209 [26]Sichuan Cancer hospital ( Site 1327),Chengdu,Sichuan,China,610042 [27]The Second People's Hospital of Neijiang ( Site 1322),Neijiang,Sichuan,China,641100 [28]Yunnan Province Cancer Hospital ( Site 1315),Kunming,Yunnan,China,650118 [29]Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328),Hangzhou,Zhejiang,China,31009 [30]Taizhou Hospital of Zhejiang Province ( Site 1329),Linhai,Zhejiang,China,317000 [31]Ningbo No. 2 Hospital ( Site 1305),Ningbo,Zhejiang,China,315010 [32]Queen Mary Hospital ( Site 3400),Hksar,Hong Kong [33]Queen Elizabeth Hospital ( Site 3402),Yau Ma Tei,Hong Kong,999077 [34]Rambam Health Care Campus-Oncology Division ( Site 2203),Haifa,Israel,3109601 [35]Shaare Zedek Medical Center ( Site 2206),Jerusalem,Israel,9103102 [36]Rabin Medical Center ( Site 2204),Petah Tikva,Israel,4941 492 [37]Sheba Medical Center ( Site 2200),Ramat Gan,Israel,5265601 [38]Chungbuk National University Hospital-Internal medicine ( Site 1000),Cheongju-si,Chungbuk,Korea, Republic of,28644 [39]National Cancer Center-Lung Cancer Center ( Site 1002),Goyang-si,Kyonggi-do,Korea, Republic of,10408 [40]Seoul National University Bundang Hospital-Medical Oncology ( Site 1003),Seongnam,Kyonggi-do,Korea, Republic of,13620 [41]The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001),Suwon-si,Kyonggi-do,Korea, Republic of,16247 [42]Keimyung University Dongsan Hospital CRC room 1 ( Site 1006),Daegu,Taegu-Kwang

关键词: Carcinoma Lung cancer non small cell lung cancer

研究目的:
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

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