CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 723 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/NCT02367781
NCT02367781Phase 3Completed
CompareCT.gov

A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

Hoffmann-La Roche·interventional·Posted Feb 20, 2015·Updated Aug 9, 2021

In Brief

A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, and 2 other interventions for Carcinoma, Non-Squamous Non-Small Cell Lung. Completed, enrolled 723 participants across 132 sites in 8 countries.

Detailed Summary

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Squamous Non-Small Cell Lung
CountriesBelgium, Canada, France, Germany, Israel, Italy, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartApr 16, 2015
Primary CompletionMar 15, 2018
Study CompletionJan 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 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. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.

Carboplatindrug

Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.

Nab-Paclitaxeldrug

Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m\^2) on Days 1, 8, and 15 of each 21-day cycle.

Pemetrexeddrug

Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.