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NCT05211895 · ClinicalTrials.gov registry record · Phase 3
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 860
- Enrollment target
- 20
- Study locations
NCT05211895: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
NCT05211895 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 860 participants, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05211895, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 860 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%. Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Durvalumab
- DRUG Domvanalimab
Study Locations (20)
Florida
- Research Site - Jacksonville
- Research Site - Orlando
- Research Site - Saint Augustine
Illinois
- Research Site - Elmhurst
- Research Site - Maywood
- Research Site - Naperville
Arizona
- Research Site - Chandler
- Research Site - Phoenix
California
- Research Site - Fountain Valley
- Research Site - Santa Rosa
Maryland
- Research Site - Baltimore
- Research Site - Silver Spring
Michigan
- Research Site - Ann Arbor
- Research Site - Detroit
Minnesota
- Research Site - Minneapolis
- Research Site - Rochester
District of Columbia
- Research Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2030-10-01 |
| Phase | Phase 3 |
What NCT05211895 shows while recruiting
NCT05211895 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (32% higher).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05211895 names 20 study sites across 11 states, led by Florida, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT05211895 about?
NCT05211895 is a clinical study titled "A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC". 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 ...
What is the current status of trial NCT05211895?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 860 participants. The study started on 2022-02-18. Estimated completion is 2030-10-01.
What conditions does trial NCT05211895 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05211895?
The interventions under investigation include: Placebo (OTHER), Durvalumab (DRUG), Domvanalimab (DRUG).
Who is sponsoring clinical trial NCT05211895?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05211895 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05211895's enrollment target sits among peer trials
860 30th of 454 higher than 425 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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