A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Fort Collins, Colorado 80528, United States
Grand Rapids, Michigan 49503, United States
Lancaster, Pennsylvania 17604, United States
Berazategui, Buenos Aires B1884BBF, Argentina
Mar del Plata, Buenos Aires B7600FZO, Argentina
ABB, Buenos Aires F.D. C1199ABB, Argentina
Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
La Rioja, F5300COE, Argentina
Linz, Upper Austria 4020, Austria
Natal, Rio Grande do Norte 59075-740, Brazil
Porto Alegre, Rio Grande do Sul 91350-200, Brazil
Rio de Janeiro, 20230-130, Brazil
Hefei, Anhui 230036, China
Beijing, Beijing Municipality 100142, China
Guangzhou, Guangdong 510515, China
Harbin, Heilongjiang 150000, China
Changsha, Hunan 410008, China
Nanjing, Jiangsu 210000, China
Nanchang, Jiangxi 330006, China
Nanchang, Jiangxi 330006, China
Xi'an, Shaanxi 710061, China
Shanghai, Shanghai Municipality 200433, China
Tianjin, Tianjin Municipality 300060, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310052, China
Valledupar, Cesar Department 200001, Colombia
Orléans, Centre-Val de Loire 45067, France
Epagny Metz-Tessy, Haute-Savoie 74370, France
Lille, Hauts-de-France 59037, France
Dortmund, North Rhine-Westphalia 44263, Germany
Lübeck, Schleswig-Holstein 23538, Germany
Berlin, 13353, Germany
Yokohama, Kanagawa 241-8515, Japan
Ina-machi, Saitama 362-0806, Japan
Koto, Tokyo 135-8550, Japan
Shinagawa, Tokyo 1428666, Japan
Saltillo, Coahuila 25279, Mexico
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Przemyśl, Podkarpackie Voivodeship 37-700, Poland
Prabuty, Pomeranian Voivodeship 82-550, Poland
Bystra, Silesian Voivodeship 43-360, Poland
Hwasun, Jeonranamdo 58128, South Korea
Songpa-gu, Seoul 05505, South Korea
Deagu, Taegu-Kwangyokshi 41404, South Korea
Daejeon, Taejon-Kwangyokshi 35015, South Korea
Las Palmas de Gran Canaria, Las Palmas 35001, Spain
Barcelona, 08035, Spain
Seville, 41009, Spain
Muang, Changwat Khon Kaen 40002, Thailand
Chiang Mai, 50200, Thailand
Üsküdar / Stanbul, Istanbul 34662, Turkey (Türkiye)
Adana, 01250, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Istanbul, 34766, Turkey (Türkiye)
London, England SW10 9NH, United Kingdom
London, London, City of EC1A 7BE, United Kingdom
London-Camden, London, City of NW1 2PG, United Kingdom