A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (NCT05211895)
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (14 items).
Location: Research Site โ Chandler, Arizona
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- EXCLUSION CRITERIA:
- History of another primary malignancy, except for:
- Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
- Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
- Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
- Mixed small cell and non-small cell lung cancer histology.
- Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
- Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
- Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- Participants with โฅ grade 2 pneumonitis from prior chemoradiation therapy.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (โฅ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (226 Sites)
- Research Site โ Chandler, Arizona
- Research Site โ Phoenix, Arizona
- Research Site โ Fountain Valley, California
- Research Site โ Santa Rosa, California
- Research Site โ Washington D.C., District of Columbia
- Research Site โ Jacksonville, Florida
- Research Site โ Orlando, Florida
- Research Site โ Saint Augustine, Florida
- Research Site โ Macon, Georgia
- Research Site โ Elmhurst, Illinois
- Research Site โ Louisville, Kentucky
- Research Site โ Baltimore, Maryland
- Research Site โ Silver Spring, Maryland
- Research Site โ Ann Arbor, Michigan
- Research Site โ Detroit, Michigan
- Research Site โ Minneapolis, Minnesota
- Research Site โ Rochester, Minnesota
- Research Site โ Reno, Nevada
- Research Site โ East Brunswick, New Jersey
- Research Site โ Columbus, Ohio
- Research Site โ Maumee, Ohio
- Research Site โ Oklahoma City, Oklahoma
- Research Site โ Pittsburgh, Pennsylvania
- Research Site โ Charleston, South Carolina
- Research Site โ Chattanooga, Tennessee
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.