NCT04665856

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Tiragolumab	Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
DRUG	Atezolizumab	Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
DRUG	Carboplatin	Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
DRUG	Etoposide	Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
DRUG	Tiragolumab Matching Placebo	Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-08-31
• Completion: 2026-06-30
• First posted: 2020-12-14
• Last updated: 2026-02-13
• Results posted: 2025-10-29

Locations

16 sites across 1 country: China

Regulatory

• FDA-regulated drug study