Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
研究单位：[1]Merck Sharp & Dohme LLC[2]VA Long Beach Healthcare System ( Site 2831),Long Beach,California,United States,90822[3]Millennium Oncology Research Clinic ( Site 2801),Hollywood,Florida,United States,33024[4]Mid Florida Hematology and Oncology Center ( Site 2800),Orange City,Florida,United States,32763[5]MFSMC-HJWCI ( Site 2804),Baltimore,Maryland,United States,21237[6]University of Massachusetts Chan Medical School ( Site 2815),Worcester,Massachusetts,United States,01655[7]Rutgers Cancer Institute of New Jersey ( Site 2805),New Brunswick,New Jersey,United States,08903[8]Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816),Portland,Oregon,United States,97227[9]Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827),Lancaster,Pennsylvania,United States,17604[10]Thomas Jefferson University - Clinical Research Institute ( Site 2813),Philadelphia,Pennsylvania,United States,19107[11]Millennium Research & Clinical Development ( Site 2811),Houston,Texas,United States,77090[12]Central Texas Veterans health care-Oncology & Hematology ( Site 2819),Temple,Texas,United States,76504[13]Canberra Hospital ( Site 0010),Canberra,Australian Capital Territory,Australia,2605[14]Icon Cancer Centre Hobart ( Site 0003),Hobart,Tasmania,Australia,7000[15]Ballarat Health Services-Medical Oncology ( Site 0002),Ballarat Central,Victoria,Australia,3350[16]Frankston Hospital-Oncology and Haematology ( Site 0009),Frankston,Victoria,Australia,3199[17]St Vincent''s Hospital-Oncology Clinical Trials ( Site 0005),Melbourne,Victoria,Australia,3065[18]Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105),Rio de Janeiro,Brazil,22793-080[19]A. C. Camargo Cancer Center-CAPEC ( Site 0102),Sao Paulo,Brazil,01509-010[20]James Lind Centro de Investigación del Cáncer ( Site 0202),Temuco,Araucania,Chile,Temuco[21]Biocenter ( Site 0208),Concepción,Biobio,Chile,4070196[22]FALP-UIDO ( Site 0205),Santiago,Region M. De Santiago,Chile,6900941[23]Centro de Oncología de Precisión ( Site 0209),Santiago,Region M. De Santiago,Chile,7560908[24]Bradfordhill ( Site 0200),Santiago,Region M. De Santiago,Chile,8420383[25]ONCOCENTRO APYS-ACEREY ( Site 0203),Viña del Mar,Valparaiso,Chile,2520598[26]Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328),Beijing,Beijing,China,100142[27]Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309),Beijing,Beijing,China,100142[28]Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300),Beijing,Beijing,China,100730[29]Fujian Provincial Cancer Hospital ( Site 0316),Fuzhou,Fujian,China,350014[30]The First Affiliated hospital of Xiamen University-oncology ( Site 0317),Xiamen,Fujian,China,361003[31]Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336),Guangzhou,Guangdong,China,510515[32]Fourth Hospital of Hebei Medical University ( Site 0331),Shijiazhuang,Hebei,China,050035[33]Henan Cancer Hospital ( Site 0333),Zhengzhou,Henan,China,450008[34]Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315),Wuhan,Hubei,China,430022[35]Hubei Cancer Hospital ( Site 0311),Wuhan,Hubei,China,430079[36]Xiangya Hospital Central South University-Oncology department ( Site 0310),Changsha,Hunan,China,410008[37]Hunan Cancer Hospital ( Site 0307),Changsha,Hunan,China,410013[38]The Second Affiliated Hospital of Soochow University ( Site 0314),Suzhou,Jiangsu,China,215004[39]Affiliated Hospital of Jiangsu University ( Site 0305),Zhenjiang,Jiangsu,China,212001[40]Jilin Cancer Hospital-oncology department ( Site 0319),Changchun,Jilin,China,132000[41]Shandong Provincial Hospital ( Site 0326),Jinan,Shandong,China,250001[42]Qingdao Central Hospital-Endocrinology ( Site 0332),Qingdao,Shandong,China,266042[43]Shanghai Chest Hospital-Radiotherapy Department ( Site 0306),Shanghai,Shanghai,China,200030[44]Fudan University Shanghai Cancer Center ( Site 0304),Shanghai,Shanghai,China,200032[45]Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335),Shanghai,Shanghai,China,200433[46]Shanxi Cancer Hospital-Pulmonology ( Site 0322),Taiyuan,Shanxi,China,030000[47]West China Hospital of Sichuan University ( Site 0324),Cheng Du,Sichuan,China[48]Tianjin Medical University Cancer Institute and Hospital-radiotherapy ( Site 0329),Tianjin,Tianjin,China,300060[49]Hangzhou Cancer Hospital-Medical Oncology ( Site 0302),Hangzhou,Zhejiang,China,310002[50]The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301),Hangzhou,Zhejiang,China,310009[51]Zhejiang Cancer Hospital ( Site 0308),Hangzhou,Zhejiang,China,310022[52]CIMCA ( Site 0501),San José,San Jose,Costa Rica,10103[53]Hospital Metropolitano - Sede Lindora ( Site 0503),Santa Ana,San Jose,Costa Rica,10903[54]Instituto de Oncologia ( Site 3003),Santo Domingo,Distrito Nacional,Dominican Republic,10102[55]Onconet ( Site 3002),Distrito Nacional,Santo Domingo,Dominican Republic,10148[56]Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607),Chemnitz,Sachsen,Germany,09116[57]LungenClinic Grosshansdorf-Onkologie ( Site 0602),Grosshansdorf,Schleswig-Holstein,Germany,22927[58]Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703),Athens,Attiki,Greece,115 26[59]Sotiria Thoracic Diseases Hospital of Athens ( Site 0704),Athens,Attiki,Greece,11527[60]Metropolitan Hospital ( Site 0702),Athens,Attiki,Greece,185 47[61]University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700),Heraklion,Irakleio,Greece,715 00[62]Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802),Ciudad de Guatemala,Guatemala,01010[63]Centro Regional de Sub Especialidades Médicas SA ( Site 0801),Quetzaltenango,Guatemala,09001[64]Centro Medico Integral De Cancerología (CEMIC) ( Site 0805),Quetzaltenango,Guatemala,09002[65]Rambam Health Care Campus-Oncology ( Site 1001),Haifa,Israel,3109601[66]Sheba Medical Center-ONCOLOGY ( Site 1000),Ramat Gan,Israel,5265601[67]Sourasky Medical Center ( Site 1002),Tel Aviv,Israel,6423906[68]Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101),Roma,Lazio,Italy,00128[69]Ospedale San Raffaele ( Site 1104),Milano,Lombardia,Italy,20132[70]Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100),Milan,Lombardia,Italy,20133[71]Fondazione IRCCS Policlinico San Matteo ( Site 1103),Pavia,Lombardia,Italy,27100[72]National Hospital Organization Shikoku Cancer Center ( Site 1211),Matsuyama,Ehime,Japan,791-0280[73]Kurume University Hospital ( Site 1212),Kurume,Fukuoka,Japan,830-0011[74]Kobe Minimally Invasive Cancer Center ( Site 1210),Kobe,Hyogo,Japan,650-0046[75]Kanagawa cancer center ( Site 1204),Yokohama,Kanagawa,Japan,241-8515[76]Miyagi Cancer Center ( Site 1200),Natori,Miyagi,Japan,981-1293[77]Sendai Kousei Hospital ( Site 1213),Sendai,Miyagi,Japan,9800873[78]Niigata Cancer Center Hospital ( Site 1205),Niigata-shi,Niigata,Japan,951-8566[79]Kansai Medical University Hospital ( Site 1207),Hirakata,Osaka,Japan,573-1191[80]Osaka Medical and Pharmaceutical University Hospital ( Site 1208),Takatsuki,Osaka,Japan,569-8686[81]Saitama Prefectural Cancer Center ( Site 1201),Ina-machi,Saitama,Japan,362-0806[82]Japanese Foundation for Cancer Research ( Site 1202),Koto,Tokyo,Japan,135-8550[83]Showa University Hospital ( Site 1203),Shinagawa,Tokyo,Japan,1428666[84]Osaka International Cancer Institute ( Site 1209),Osaka,Japan,541-8567[85]Chungbuk National University Hospital-Internal medicine ( Site 2400),Cheongju-si,Chungbuk,Korea, Republic of,28644[86]The Catholic University Of Korea St. Vincent''s Hospital-Medical Oncology ( Site 2401),Suwon-si,Kyonggi-do,Korea, Republic of,16247[87]Ajou University Hospital-Hematology-Oncology ( Site 2402),Suwon-si,Kyonggi-do,Korea, Republic of,16499[88]Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403),Seoul,Korea, Republic of,03722[89]University Malaya Medical Centre-Clinical Oncology ( Site 1402),Lembah Pantai,Kuala Lumpur,Malaysia,59100[90]Hospital Pulau Pinang ( Site 1400),George Town,Pulau Pinang,Malaysia,10990[91]Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401),Kuala Lumpur,Malaysia,50586[92]Arké SMO S.A. de C.V. ( Site 1504),Mexico,Distrito Federal,Mexico,06700[93]Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505),Guadalajara,Jalisco,Mexico,44680[94]Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507),Chihuahua,Mexico,31217[95]Centro de Investigacion Clinica de Oaxaca ( Site 1501),Oaxaca,Mexico,68020[96]Hospital CUF Descobertas ( Site 2006),Lisbon,Lisboa,Portugal,1998-018[97]HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit,Barcelona,Cataluna,Spain,08036[98]CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502),Santiago de Compostela,La Coruna,Spain,15706[99]HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504),Pozuelo de Alarcon,Madrid,Spain,28223[100]Hospital Universitari Vall d''Hebron ( Site 2501),Barcelona,Spain,08035[101]Medipol Mega Universite Hastanesi-oncology ( Site 2611),Stanbul,Istanbul,Turkey,34214[102]Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603),Bornova,Izmir,Turkey,35100[103]I.E.U. Medical Point Hastanesi-Oncology ( Site 2612),Izmir, Karsiyaka,Izmir,Turkey,35575[104]Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607),Adana,Turkey,01250[105]Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602),Ankara,Turkey,06010[106]Hacettepe Universitesi-oncology hospital ( Site 2605),Ankara,Turkey,06230[107]Memorial Ankara Hastanesi-Medical Oncology ( Site 2609),Ankara,Turkey,06520[108]Ankara City Hospital-Medical Oncology ( Site 2601),Ankara,Turkey,06800[109]TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610),Istanbul,Turkey,34722
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.
