drugset / 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

NCT04619797

Phase 2/3 Completed 542 enrolled Hoffmann-La Roche
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2020-12-15
Primary completion
2024-04-19
Completion
2025-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Tiragolumab Monoclonal antibody 600 mg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous