A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Inclusion Criteria:
Exclusion Criteria:
Zion, Illinois 60099, United States
Salzburg, 5020, Austria
Praha 4 - Krc, 140 59, Czechia
Pisa, Tuscany 56124, Italy
Kyoto, 602-8566, Japan
Osaka, 591-8555, Japan
Satima, 362-0806, Japan
Tokyo, 113-8677, Japan
Wakayama, 641-8509, Japan
Lodz, 93-513, Poland
Olsztyn, 10-357, Poland
Moscovskaya Oblast, Moscow Oblast 143423, Russia
Moscow, Moscow Oblast 105229, Russia
Moscow, Moscow Oblast 115478, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia