OncRef

Clinical Trial: NCT04619797

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-06-03

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).

Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:

  • Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin
  • Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin

Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

Official Title

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

Conditions

Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment

  • Drug: Tiragolumab
  • Drug: Atezolizumab
  • Drug: Pemetrexed
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Drug: Tiragolumab Matching Placebo
  • Drug: Pembrolizumab

Other Study ID Numbers

  • BO42592
  • 2020-002851-39
  • 2022-502031-20-00

Start Date (Actual)

2020-12-15

Primary Completion Date (Actual)

2024-04-19

Study Completion Date (Actual)

2025-11-20

Enrollment (Actual)

542

Study Type

Interventional

Phase

Phase 2, Phase 3