CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 578 enrolled
Drug / intervention
Atezolizumab +3 moredrug
Likely dose
Atezolizumab 1200 mgfrom 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/NCT02657434
NCT02657434Phase 3Completed
CompareCT.gov

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

Hoffmann-La Roche·interventional·Posted Jan 15, 2016·Updated Nov 21, 2023

In Brief

A Phase 3 clinical trial evaluating Atezolizumab, Carboplatin, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 578 participants across 183 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Chile, China, France, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, Peru, Portugal, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 15, 2016
Enrollment StartApr 30, 2016
Primary CompletionJul 18, 2019
Study CompletionDec 13, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.5 years ago

Interventions

Atezolizumabdrug

Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.

Carboplatindrug

Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.

Cisplatindrug

Participants received IV infusion of 75 mg/m\^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.

Pemetrexeddrug

Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.