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Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

NCT02486718 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2026-04-30

Study results available
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Summary

This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

Conditions

Interventions

DRUG

Atezolizumab

Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).

DRUG

Cisplatin

Participants will receive cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of up to four 21-day cycles.

DRUG

Vinorelbine

Participants will receive vinorelbine 30 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.

DRUG

Docetaxel

Participants will receive docetaxel 75 mg/m\^2 IV on Day 1 of each of the four 21-day cycles.

DRUG

Gemcitabine

Participants will receive gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.

DRUG

Pemetrexed

Participants will receive pemetrexed 500 mg/m\^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2024-01-26
Completion
2027-08-31

Countries

  • United States
  • Australia
  • Belgium
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486718 on ClinicalTrials.gov