drugset / Trial / NCT02657434

A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)

NCT02657434

Phase 3 Completed 578 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

Timeline

Start
2016-04-30
Primary completion
2019-07-18
Completion
2022-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous