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

Conditions

• Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Feb 4, 2020

Status verified

Mar 2026

Primary completion

Sep 6, 2022

Completion

Jul 31, 2025

Study Design

Enrollment

490 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Placebo + Atezolizumab + CE
  Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
• Experimental: Tiragolumab + Atezolizumab + CE
  Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.

Primary Outcome Measure

Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) [ Time Frame: From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months) ]

Locations (18)

Related coverage on Hipa.ai

• Atezolizumab + Tiragolumab Shows No Significant Benefit in ES-SCLC
  Atezolizumab · Oct 22, 2025 · ClinicalTrials.gov

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