drugset / Trial / NCT02409355

A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

NCT02409355

Phase 3 Terminated 8 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Timeline

Start
2015-05-07
Primary completion
2017-12-07
Completion
2017-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Comparator Carboplatin Small molecule Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1250 mg/m2 Intravenous