CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,202 enrolled
Drug / intervention
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody +3 moredrug
Likely dose
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody 1200 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02366143
NCT02366143Phase 3Completed
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A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

Hoffmann-La Roche·interventional·Posted Feb 19, 2015·Updated Sep 23, 2021

In Brief

A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, and 2 other interventions for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 1,202 participants across 240 sites in 26 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, France, Germany, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Russia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartMar 31, 2015
Primary CompletionSep 13, 2019
Study CompletionDec 7, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.4 years ago

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibodydrug

Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.

Bevacizumabdrug

Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.

Carboplatindrug

Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.

Paclitaxeldrug

Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m\^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.