drugset / Trial / NCT02366143

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT02366143 ↗

Phase 3 Completed 1202 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).

Timeline

Start
2015-03-31
Primary completion
2019-09-13
Completion
2020-12-07

Outcome

Mixed primary results

registry Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) vs Arm C (Bevacizumab+Paclitaxel+Carboplatin); p <0.0001; Hazard Ratio (HR) 0.62 NCT02366143 ↗

registry Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) vs Arm C (Bevacizumab+Paclitaxel+Carboplatin); p = 0.0164; Hazard Ratio (HR) 0.78 NCT02366143 ↗

registry Arm A (Atezolizumab+Paclitaxel+Carboplatin) vs Arm C (Bevacizumab+Paclitaxel+Carboplatin); p = 0.0528; Hazard Ratio (HR) 0.842 NCT02366143 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous