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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Hoffmann-La Roche
Study ID
NCT02486718
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
  • Cisplatin — DRUG
    Participants will receive cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of up to four 21-day cycles.
  • Vinorelbine — DRUG
    Participants will receive vinorelbine 30 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.
  • Docetaxel — DRUG
    Participants will receive docetaxel 75 mg/m\^2 IV on Day 1 of each of the four 21-day cycles.
  • Gemcitabine — DRUG
    Participants will receive gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.
  • Pemetrexed — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2015
Status verified
Apr 2026
Primary completion
Jan 26, 2024
Completion
Aug 31, 2027

Study Design

Enrollment
1,280 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    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.
  • Active Comparator: Best Supportive Care
    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.

Primary Outcome Measure

Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population [ Time Frame: Up to 95 months ]

Locations (32)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
California Cancer Associates for Research & Excellence, Inc.EncinitasCalifornia92024-
Compassionate Cancer Care Medical Group, IncFountain ValleyCalifornia92708-
University of California Los AngelesLos AngelesCalifornia90024-
Kaiser PermanenteVallejoCalifornia94589-
Kaiser Permanente - Walnut CreekWalnut CreekCalifornia94596-
Eastern Connecticut Hematology and Oncology AssociatesNorwichConnecticut06360-
Lynn Cancer Institute - WestBoca RatonFlorida33486-
University of Miami School of Medicine - Sylvester at DeerfieldDeerfield BeachFlorida33442-
SCRI Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
Lewis Hall Singletary Oncology CenterThomasvilleGeorgia31792-
University of Illinois at ChicagoChicagoIllinois60612-
Illinois Cancer CarePeoriaIllinois61615-
Norton Cancer InstituteLouisvilleKentucky40402-
St. Luke's Cancer InstituteKansas CityMissouri64111-
Hematology Oncology Associates of Northern New JerseyFlorham ParkNew Jersey07932-
Saint Barnabas Medical CenterLivingstonNew Jersey07039-
Valley HospitalParamusNew Jersey07652-
Overlook Medical CenterSummitNew Jersey07901-
Clinical Research AllianceLake SuccessNew York11042-
Weill Cornell Medical CollegeNew YorkNew York10065-
Presbyterian HospitalCharlotteNorth Carolina28204-
Oncology Hematology Care - SCRICincinnatiOhio45242-
University of CincinnatiCincinnatiOhio45219-
Oregon Health and Science UniversityPortlandOregon97239-
University Oncology AssociatesChattanoogaTennessee37403-
Houston Methodist Cancer CenterHoustonTexas77030-
Wellmont Medical AssociatesBristolVirginia24201-
Hematology Oncology Associates of Fredericksburg, Inc.FredericksburgVirginia22408-
MultiCare Regional Cancer Center - AuburnAuburnWashington98002-4117-
Providence Everett Med CtrEverettWashington98201-
Swedish Medical CenterSeattleWashington98122-

Related coverage on Hipa.ai

Find similar trials in Fayetteville, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group· Fayetteville, ARCalifornia Cancer Associates for Research & Excellence, Inc.· Encinitas, CACompassionate Cancer Care Medical Group, Inc· Fountain Valley, CAUniversity of California Los Angeles· Los Angeles, CAKaiser Permanente· Vallejo, CAKaiser Permanente - Walnut Creek· Walnut Creek, CA

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