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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]

StatusCompleted
PhasePhase 3
Started2015-10-31
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 83 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-10-01
Trial completed
Trial sites expanded: 155 → 216 locations
Study completion confirmed: August 2026 (last estimated August 2027)
2026-07-27
Study Status, Contacts/Locations v82
Study sites154→155
2026-04-28
Study Status, Contacts/Locations v81
Study sites153→154
2026-01-16
Study Status, Outcome Measures, Outcome Measures (Results) v80
Completion date2027-12-17→2027-08-31
Secondary endpointsdetails revised at 2 of 12 entries
2025-12-19
Study Status v79
Completion date2035-08-30→2027-12-17
Show 45 earlier versions
2025-09-30
Study Status, Contacts/Locations v78
Study sites152→153
2025-07-02
Study Status, Contacts/Locations, IPDSharing v77
Study sites229→152
2025-03-27
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v76
Results first postednot stated→2025-03-30
Secondary endpoints8 to 12 entries
Percentage of Participants Who are Disease-Freefree Rate at Year 3, Assessedin UsingITT CT/MRI/XPopulation Disease-Rayfree Rate at Year 3 in All Randomized Stage II-IIIA Population Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population Disease-free Rate at Year 5 in ITT Population Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population Disease-free Rate [...] Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray DFS Within Selected Populations Percentage of Participants withWith Adverse Events (AEs)
Primary endpoints1 to 3 entries
DFS in All Randomized Stage II-IIIA Population DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population Disease-Free Survival (DFS), Assessedin Using Computed TomographyIntent-to-treat (CTITT)/Magnetic Resonance Imaging (MRI)/X-RayPopulation
2024-09-16
Study Status, Outcome Measures, Contacts/Locations v75
Secondary endpointsdetails revised at 1 of 8 entries
Study sitesdetails revised at 1 of 229 sites
2024-08-19
Study Identification, Study Status, Contacts/Locations v74
Study sitesdetails revised at 2 of 229 sites
2024-05-23
Study Status, Contacts/Locations v73
Study sites229 entries, revised
SCRISarah Cannon Research Institute / Tennessee Oncology Chattanooga Sarah Cannon CancerResearch CenterInstitute / Tennessee Oncology LungenClinic GroßhansdorfGrosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika TudogyogyintezetReformatus TorokbalintPulmonologiai Centrum
2024-02-23
Study Status, Contacts/Locations v72
Primary completion dateestimated 2024-08-30→confirmed 2024-01-26
Study sites229 entries, revised
MunicipalCommunal InstitutionNonprofit PodilskiyEnterprise Podilsky Regional Center ofOf Oncology; DepartmentOfTheVinnytsia ofRegional ChemotherapyCouncil
2024-01-31
Study Status, Contacts/Locations v71
Study sitesdetails revised at 1 of 229 sites
2023-11-01
Study Status v70
Re-verified, no change to tracked fields
2023-08-03
Study Status, Contacts/Locations v69
Primary completion date2023-12-01→2024-08-30
Completion date2027-12-17→2035-08-30
Study sitesdetails revised at 6 of 229 sites
2023-05-04
Study Status, Contacts/Locations v68
Study sites229 entries, revised
SCRI Mark H. Zangmeister Center
2023-02-05
Study Status, Contacts/Locations v67
Study sites229 entries, revised
Centro Hospitalar de Lisboa Norte E.P.E -? Hospital Pulido Valente ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'?k Regional Council; Chemotherapy Department
2022-11-07
Study Status, Contacts/Locations v66
Study sitesdetails revised at 1 of 229 sites
2022-08-12
Study Status v65
Re-verified, no change to tracked fields
2022-05-17
Study Status, Contacts/Locations v64
Study sites230→229
2022-02-17
Study Status, Contacts/Locations v63
Primary completion date2022-08-01→2023-12-01
Study sites230 entries, revised
KlinikSLK LoewensteinKliniken gGmbHHeilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal Moscow cityCity oncologyOncology hospitalHospital #62 of Moscow Healthcare Department
2021-11-30
Study Status, Contacts/Locations v62
Primary completion date2021-11-06→2022-08-01
Study sites231→230
2021-08-31
Study Status, Contacts/Locations v61
Study sites231 entries, revised
State Budgetary Institution of Health VolzhskiiVolgograd Regional Clinical Oncology Dispensary #3
2021-06-09
Study Status, Contacts/Locations v60
Study sites231 entries, revised
Northwest Georgia Oncology Centers, P.C.a Service of Wellstar Cobb Hospital
2021-03-15
Study Status, Contacts/Locations v59
Study sitesdetails revised at 2 of 231 sites
2020-12-21
Study Status, Contacts/Locations v58
Study sitesdetails revised at 2 of 231 sites
2020-10-01
Study Status, Outcome Measures, Contacts/Locations v57
Primary completion date2020-11-26→2021-11-06
Secondary endpointsdetails revised at 3 of 8 entries
Study sitesdetails revised at 1 of 231 sites
2020-08-17
Study Status, Contacts/Locations v56
Study sitesdetails revised at 2 of 231 sites
2020-05-26
Study Status, Contacts/Locations v55
Study sitesdetails revised at 2 of 231 sites
2020-03-04
Study Status, Contacts/Locations v54
Study sites231 entries, revised
MIME KryvyiKryviy Rih Oncology Dispensary of DnipropetrovskDnipropetrovs'k Regional Council; Chemotherapy Department
2019-12-09
Study Status v53
Re-verified, no change to tracked fields
2019-11-25
Study Status, Contacts/Locations v52
Study sites303→231
2019-10-07
Study Status, Contacts/Locations v51
Study sites303 entries, revised
LungenClinic Großhansdorf GmbH Pius-Hospital Oldenburg
2019-09-04
Study Status, Contacts/Locations v50
Study sitesdetails revised at 1 of 303 sites
2019-07-18
Study Status, Contacts/Locations v49
Study sitesdetails revised at 3 of 303 sites
2019-04-22
Study Status, Contacts/Locations v48
Study sitesdetails revised at 4 of 303 sites
2019-01-29
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v47
Primary completion date2026-09-25→2020-11-26
Completion date2026-09-25→2027-12-17
Enrollment targetestimated 1127→confirmed 1280
Eligibility criteria+16 characters
[...] e study Administration of a live, attenuated vaccine within 284 daysweeks prior to randomizationinitiation of study treatment or anticipation that such a live attenuated vaccine will be [...]
Secondary endpoints7 to 8 entries
Overall Survival (OS) in the ITT Population DFS Within Selected Populations Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Primary endpoints2 to 1 entries
Disease-Free Survival (DFS, Assessed Using CT/MRI/X-Ray in Stage II-IIIA and PD-L1-Selected Subpopulation DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray in in Stage IB-IIIA (Intent-to-Treat [ITT]) Population
Study sitesdetails revised at 2 of 303 sites
2019-01-07
Study Status, Contacts/Locations v46
Study sites305→303
2018-10-08
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v45
Trial statusRecruiting→Active, Not Recruiting
Study sites306→305
2018-10-01
Study Status, Contacts/Locations v44
Study sites305→306
2018-09-10
Study Status, Contacts/Locations v43
Study sites306→305
2018-08-16
Study Status, Contacts/Locations v42
Study sites307→306
2018-07-23
Study Status, Contacts/Locations v41
Study sitesdetails revised at 16 of 307 sites
2018-07-02
Study Status, Contacts/Locations v40
Study sites306→307
2018-06-11
Study Status, Contacts/Locations v39
Study sitesdetails revised at 8 of 306 sites
2018-05-22
Study Status, Contacts/Locations v38
Study sites306 entries, revised
RegionalHematology Cancer CareOncology Associates LLCof Northern New Jersey
2018-04-30
Study Status, Contacts/Locations v37
Study sites305→306
2018-04-09
Study Status, Contacts/Locations v36
Study sitesdetails revised at 3 of 305 sites
2018-03-19
Study Status, Contacts/Locations v35
Study sites306→305
2018-02-27
Study Status, Contacts/Locations v34
Study sites306 entries, revised
VinnytsiaMunicipal Institution Podilskiy Regional CouncilCenter Vinnytsiaof Regional Clinical Oncological DispensaryOncology; DptDepartment of Chemotherapy
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 Details
NCT Number NCT02486718
Lead Sponsor Hoffmann-La Roche
Conditions Non-Small Cell Lung Cancer
Enrollment 1,280 participants
Start Date 2015-10-31
Primary Completion 2024-01-26 (estimated)
Study Completion 2026-08-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-30