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 — DRUGAtezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
- Tiragolumab — DRUGTiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
- Durvalumab — DRUGDurvalumab 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 + TiragolumabParticipants 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: DurvalumabParticipants 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)
Related coverage on Hipa.ai
- Atezolizumab + Tiragolumab Phase 3 NSCLC Trial Shows Similar Efficacy to…Atezolizumab · Jun 3, 2026 · ClinicalTrials.gov
- Atezolizumab Phase 3 Trial for NSCLC Reaches Primary CompletionAtezolizumab · May 27, 2025 · ClinicalTrials.gov
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