A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008)
A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008)
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.
With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.
Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Los Angeles, California 90017, United States
Boca Raton, Florida 33486, United States
Grand Rapids, Michigan 49503, United States
Lancaster, Pennsylvania 17601, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Mar del Plata, Buenos Aires B7600FZO, Argentina
Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
Melbourne, Victoria 3021, Australia
Linz, Upper Austria 4020, Austria
Vienna, 1140, Austria
Kingston, Ontario K7L 2V7, Canada
Beijing, Beijing Municipality 100142, China
Beijing, Beijing Municipality 100730, China
Harbin, Heilongjiang 150000, China
Wuhan, Hubei 430048, China
Xi'an, Shaanxi 710061, China
Shanghai, Shanghai Municipality 200030, China
Oulu, North Ostrobothnia 90220, Finland
Turku, Southwest Finland 20520, Finland
Marseille, Bouches-du-Rhone 13915, France
Toulouse, Haute-Garonne 31400, France
Limoges, Haute-Vienne 87042, France
Heidelberg, Baden-Wurttemberg 69126, Germany
Hanover, Lower Saxony 30625, Germany
Athens, Attica 115 26, Greece
Kecskemét, Bács-Kiskun county 6000, Hungary
Győr, Győr-Moson-Sopron 9024, Hungary
Törökbálint, Pest County 2045, Hungary
Kaposvár, Somogy County 7400, Hungary
Dublin, Dublin 9, Ireland
Naples, Campania 80131, Italy
Koto, Tokyo 135-8550, Japan
Klaipėda, Klaipedos Miestas 92288, Lithuania
Vilnius, Vilniaus Miestas 08660, Lithuania
Kaunas, LT-50161, Lithuania
Guadalajara, Jalisco 44680, Mexico
Siedlce, Masovian Voivodeship 08-110, 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
Porto, 4200-072, Portugal
Bucharest, Bucharest 022343, Romania
Hwasun, Jeonranamdo 58128, South Korea
Deagu, Taegu-Kwangyokshi 41404, South Korea
Daejeon, Taejon-Kwangyokshi 35015, South Korea
Madrid, Madrid, Comunidad de 28041, Spain
Barcelona, 08035, Spain
Seville, 41009, Spain
Bornova, İzmir 35100, Turkey (Türkiye)
Adana, 01250, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)