NCT02486718|Active Not RecruitingPhase 3Results

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

A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Hoffmann-La Roche ClinicalTrials.gov

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3 other identifiers

GO295272014-003205-152023-505981-26-00

Study Type

interventional

Target

1,280

Locations

21 countries

Sites

154

Timeline

RegisteredJul 2015

StartedOct 2015

CompletionAug 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,280

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline

16mo left

Started Oct 2015

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

21 countries

154 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.8 years study duration

Study Progress89%

Oct 2015Aug 2027

First Submitted

Initial submission to the registry

June 4, 2015

Completed

27 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

October 31, 2015

Completed

8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2024

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 30, 2025

Completed

2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Expected

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8.2 years

First QC Date

June 4, 2015

Results QC Date

December 12, 2024

Last Update Submit

April 28, 2026

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Up to 95 months
DFS in All Randomized Stage II-IIIA Population
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Up to 95 months
DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Up to 95 months

Secondary Outcomes (12)

Overall Survival (OS) in the ITT Population
Baseline up to death from any cause (up to approximately 126 months)
Disease-free Rate at Year 3 in ITT Population
Year 3
Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
Year 3
Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
Year 3
Disease-free Rate at Year 5 in ITT Population
Year 5
+7 more secondary outcomes

Study Arms (2)

Atezolizumab

EXPERIMENTAL

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.

Drug: AtezolizumabDrug: CisplatinDrug: VinorelbineDrug: DocetaxelDrug: GemcitabineDrug: Pemetrexed

Best Supportive Care

ACTIVE COMPARATOR

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.

Drug: CisplatinDrug: VinorelbineDrug: DocetaxelDrug: GemcitabineDrug: Pemetrexed

Interventions

AtezolizumabDRUG

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

Also known as: MPDL3280A; TECENTRIQ

Atezolizumab

CisplatinDRUG

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