At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Tiragolumab, Atezolizumab, and 3 other interventions for Small Cell Lung Cancer. Completed, enrolled 490 participants across 121 sites in 23 countries.
Detailed 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).
Study Details
Timeline
Interventions
Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Placebo administered by IV infusion on Day 1 of each 21-day cycle.