NCT04256421

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tiragolumab	Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Atezolizumab	Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Carboplatin	Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
DRUG	Etoposide	Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
DRUG	Placebo	Placebo administered by IV infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2020-02-04
• Primary completion: 2022-09-06
• Completion: 2025-07-31
• First posted: 2020-02-05
• Last updated: 2026-04-03
• Results posted: 2025-10-22

Locations

121 sites across 23 countries: United States, Australia, Austria, Belgium, Brazil, Czechia, Germany, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Russia, Serbia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study