An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90048, United States
Colorado Springs, Colorado 80907, United States
Kansas City, Missouri 64132, United States
Ciudad Autonoma Buenos Aires, C1426ANZ, Argentina
Santo André, 09060-650, Brazil
Alberta, T2N 4N2, Canada
Ontario, L3Y 2P9, Canada
Créteil, Val De Marne 94010, France
Bouches-du-Rhône, 13915, France
Toulouse, 31059, France
Bologna, 40138, Italy
Catania, 95123, Italy
Catanzaro, 88100, Italy
Naples, 80131, Italy
Hidaka-shi, Japan
Kitaadachigun, 362-0806, Japan
Kurume-shi, 830-0011, Japan
Osakasayama-sh, 589-8511, Japan
L'Hospitalet de Llobregat, 08908, Spain
Ankara, 06105, Turkey (Türkiye)
Dnipro, 49102, Ukraine
Ivano-Frankivsk, 76018, Ukraine
Lutsk, 43018, Ukraine
Uzhhorod, 88000, Ukraine