CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,021 enrolled
Drug / intervention
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody +3 moredrug
Likely dose
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (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.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02367794
NCT02367794Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Feb 20, 2015·Updated Mar 21, 2022

In Brief

A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin, and 2 other interventions for Squamous Non-Small Cell Lung Cancer. Completed, enrolled 1,021 participants across 242 sites in 26 countries.

Detailed Summary

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartJun 11, 2015
Primary CompletionOct 3, 2018
Study CompletionFeb 17, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.4 years ago

Interventions

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibodydrug

Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

Carboplatindrug

Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

Nab-Paclitaxeldrug

Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

Paclitaxeldrug

Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV.