A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04513925
Phase
PHASE3
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
  • Durvalumab — DRUG
    Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight \>/= 30 kg) on Day 1 of each 28-day cycle.

Study Details

The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

Key Dates

Start date
Aug 24, 2020
Status verified
May 2026
Primary completion
May 27, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
829 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Tiragolumab
    Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.
  • Active Comparator: Durvalumab
    Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.

Primary Outcome Measure

Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS) [ Time Frame: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-
Banner MD Anderson Cancer CenterGreeleyColorado80631-
Florida Cancer SpecialistsFort MyersFlorida33901-8101-
Cancer Care Centers of BrevardPalm BayFlorida32901-
Woodlands Medical Specialists, P.A.PensacolaFlorida32503-
Florida Cancer Specialist, North RegionSt. PetersburgFlorida33705-
Northwest Georgia Oncology Centers PC - MariettaMariettaGeorgia30060-
Illinois Cancer CarePeoriaIllinois61615-
New England Cancer SpecialistsBrunswickMaine04011-
Southcoast Health SystemFairhavenMassachusetts02719-
Minnesota Oncology HematologyMinneapolisMinnesota55404-
HCA Midwest HealthKansas CityMissouri64132-
Cox Health SystemsSpringfieldMissouri65807-
Comprehensive Cancer Centers of NevadaLas VegasNevada89128-
Optum Health CareLas VegasNevada89106-
Titan Health Partners LLC, d/b/a Astera Cancer CareEast BrunswickNew Jersey08816-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
New York Oncology Hematology,P.C.-AlbanyAlbanyNew York12208-
Mount Sinai Medical CenterNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10461-
Prisma Health ? UpstateGreenvilleSouth Carolina29615-
Tennessee Oncology ChattanoogaChattanoogaTennessee37403-
Sarah Cannon Research Institute / Tennessee OncologyNashvilleTennessee37203-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Oncology AssociatesNorfolkVirginia23502-

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