CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,225 enrolled
Drug / intervention
Atezolizumab +1 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/NCT02008227
NCT02008227Phase 3Completed
CompareCT.gov

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy

Hoffmann-La Roche·interventional·Posted Dec 11, 2013·Updated Dec 20, 2019

In Brief

A Phase 3 clinical trial evaluating Atezolizumab and Docetaxel for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 1,225 participants across 208 sites in 31 countries.

Detailed Summary

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Squamous Non-Small Cell Lung Cancer
CountriesArgentina, Austria, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 11, 2013
Enrollment StartMar 11, 2014
Primary CompletionJul 7, 2016
Study CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.6 years ago

Interventions

Atezolizumabdrug

1200 mg IV infusion on Day 1 of each 21-day cycle

Docetaxeldrug

75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle