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Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

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研究单位: [1]Merck Sharp & Dohme LLC [2]Los Angeles Hematology Oncology Medical Group ( Site 0006),Los Angeles,California,United States,90017 [3]Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014),Boca Raton,Florida,United States,33486 [4]Fort Wayne Medical Oncology and Hematology ( Site 0013),Fort Wayne,Indiana,United States,46804 [5]Cancer and Hematology Centers of Western Michigan ( Site 0001),Grand Rapids,Michigan,United States,49503 [6]Hattiesburg Clinic Hematology/Oncology ( Site 0003),Hattiesburg,Mississippi,United States,39401 [7]Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005),Lancaster,Pennsylvania,United States,17604 [8]Blue Ridge Cancer Care ( Site 0015),Blacksburg,Virginia,United States,24060 [9]University of Virginia Cancer Center ( Site 0019),Charlottesville,Virginia,United States,22903 [10]Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201),Mar del Plata,Buenos Aires,Argentina,7600 [11]Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203),ABB,Caba,Argentina,C1199ABB [12]Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200),Buenos Aires,Caba,Argentina,C1431FWO [13]Sanatorio Parque ( Site 0202),Rosario,Santa Fe,Argentina,2000 [14]Hospital Provincial del Centenario ( Site 0205),Rosario,Santa Fe,Argentina,2002 [15]Nepean Hospital ( Site 2700),Penrith,New South Wales,Australia,2747 [16]Calvary Mater Newcastle ( Site 2703),Waratah,New South Wales,Australia,2298 [17]Frankston Hospital-Oncology and Haematology ( Site 2702),Frankston,Victoria,Australia,3199 [18]Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701),St Albans,Victoria,Australia,3021 [19]Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505),Linz,Oberosterreich,Austria,4020 [20]Kepler Universitätsklinikum ( Site 0507),Linz,Oberosterreich,Austria,4021 [21]Medizinische Universität Graz ( Site 0504),Graz,Steiermark,Austria,8036 [22]Klinik Penzing-2. Lungenabteilung ( Site 0502),Vienna,Wien,Austria,1140 [23]Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501),Wien,Austria,1210 [24]Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106),Kingston,Ontario,Canada,K7L 2V7 [25]Lakeridge Health ( Site 0102),Oshawa,Ontario,Canada,L1G 2B9 [26]Anhui Cancer Hospital ( Site 2915),Hefei,Anhui,China,230031 [27]Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901),Beijing,Beijing,China,100142 [28]Beijing Peking Union Medical College Hospital ( Site 2921),Beijing,Beijing,China,100730 [29]Fujian Provincial Cancer Hospital-oncology department ( Site 2904),Fuzhou,Fujian,China,350014 [30]Harbin Medical University Cancer Hospital-oncology of department ( Site 2920),Harbin,Heilongjiang,China,150000 [31]Henan Cancer Hospital ( Site 2916),Zhengzhou,Henan,China,450008 [32]Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912),Wuhan,Hubei,China,430022 [33]Hubei Cancer Hospital ( Site 2922),Wuhan,Hubei,China,430079 [34]Hunan Cancer Hospital ( Site 2907),Changsha,Hunan,China,410013 [35]The First Affiliated Hospital of Soochow University ( Site 2913),Suzhou,Jiangsu,China,215006 [36]Jilin Cancer Hospital-GCP office ( Site 2909),Changchun,Jilin,China,130000 [37]The First Hospital of Jilin University ( Site 2914),Changchun,Jilin,China,130021 [38]The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910),Xi''an,Shaanxi,China,710061 [39]Shanghai Chest Hospital-Oncology department ( Site 2900),Shanghai,Shanghai,China,200030 [40]Fudan University Shanghai Cancer Center ( Site 2908),Shanghai,Shanghai,China,200032 [41]Sichuan Cancer hospital ( Site 2923),Chengdu,Sichuan,China,610041 [42]West China Hospital Sichuan University ( Site 2903),Chengdu,Sichuan,China,610041 [43]Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906),Hangzhou,Zhejiang,China,310016 [44]Zhejiang Cancer Hospital-Oncology ( Site 2919),Hangzh

研究目的:
This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

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