drugset / Trial / NCT04256421

A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04256421

Phase 3 Completed 490 enrolled Hoffmann-La Roche
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Timeline

Start
2020-02-04
Primary completion
2022-09-06
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiragolumab Monoclonal antibody 600 mg Intravenous
Background Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Carboplatin Small molecule Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous