drugset / Trial / NCT02409342

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

NCT02409342 ↗

Phase 3 Completed 572 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

Timeline

Start
2015-07-20
Primary completion
2020-02-04
Completion
2022-03-08

Outcome

Mixed primary results

paper Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type. PMID 32997907 ↗

registry Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) vs Atezolizumab; p = 0.3091; Hazard Ratio (HR) 0.868 (95% CI 0.661 to 1.140); Log Rank NCT02409342 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Carboplatin Small molecule 6 unknown 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
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous