A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
NCT05221840 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1051
Last updated 2026-05-18
Summary
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Conditions
Interventions
- DRUG
-
Oleclumab
Oleclumab IV (intravenous infusion)
- DRUG
-
Monalizumab
Monalizumab IV (intravenous infusion)
- OTHER
-
Placebo
Placebo IV (intravenous infusion)
- DRUG
-
Durvalumab IV (intravenous infusion)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Fabrice Barlesi, MD · Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-07
- Primary Completion
- 2026-06-30
- Completion
- 2030-07-02
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- China
- Colombia
- France
- Germany
- Italy
- Japan
- Peru
- Poland
- Portugal
- South Korea
- Spain
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
- Vietnam
Study Locations
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