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Clinical Trials in Canada / NCT05211895
Active, not recruiting Phase 3

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

NCT05211895 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2022-02-18
Last updated
2026-08-28

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Durvalumab →Domvanalimab →Placebo

Durvalumab: Durvalumab IV (Intravenous infusion)

Domvanalimab: Domvanalimab IV (Intravenous infusion)

Placebo: Placebo IV (Intravenous infusion)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA: 1. Participant must be ≥ 18 years at the time of screening. 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease 3. Provision of a tumour tissue sample obtained prior to CRT 4. Documented tumour PD-L1 status ≥ 1% by central lab 5. Documented EGFR and ALK wild-type status (local or central). 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy 8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. 9. WHO performance status of 0 or 1 at randomization 10. Adequate organ and marrow function EXCLUSION CRITERIA: 1. 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. 2. Mixed small cell and non-small cell lung cancer histology. 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia). 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy. 7. 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 (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 9. Active EBV infection, or known or suspected chronic active EBV infection at screening 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Primary outcome measure(s)

Trial sites (226)

FacilityCityRegionStatus
Research Site Chandler Arizona
Research Site Phoenix Arizona
Research Site Fountain Valley California
Research Site Santa Rosa California
Research Site Washington D.C. District of Columbia
Research Site Jacksonville Florida
Research Site Orlando Florida
Research Site Saint Augustine Florida
Research Site Macon Georgia
Research Site Elmhurst Illinois
Research Site Louisville Kentucky
Research Site Baltimore Maryland
Research Site Silver Spring Maryland
Research Site Ann Arbor Michigan
Research Site Detroit Michigan
Research Site Minneapolis Minnesota
Research Site Rochester Minnesota
Research Site Reno Nevada
Research Site East Brunswick New Jersey
Research Site Columbus Ohio
Research Site Maumee Ohio
Research Site Oklahoma City Oklahoma
Research Site Pittsburgh Pennsylvania
Research Site Charleston South Carolina
Research Site Chattanooga Tennessee
Research Site Nashville Tennessee
Research Site Nashville Tennessee
Research Site Fort Sam Houston Texas
Research Site Fairfax Virginia
Research Site Fort Belvoir Virginia
Research Site Spokane Valley Washington
Research Site Appleton Wisconsin
Research Site Brussels Belgium
Research Site Edegem Belgium
Research Site Haine-Saint-Paul Belgium
Research Site Leuven Belgium
Research Site Liège Belgium
Research Site Sint-Niklaas Belgium
Research Site Barretos Brazil
Research Site Londrina Brazil

+ 186 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05211895 on ClinicalTrials.gov ↗ ← All trials in Canada