Study identifier:D9108C00001
ClinicalTrials.gov identifier:NCT03822351
EudraCT identifier:2018-002931-35
CTIS identifier:N/A
A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)
Stage III Non-small Cell Lung Cancer
Phase 2
No
Durvalumab + Oleclumab, Durvalumab, Durvalumab + Monalizumab
All
189
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by MedImmune, LLC
MedImmune, LLC
-
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).
Location
Location
Wichita, KS, United States, 67214
Location
Tyler, TX, United States, 75701
Location
Gettysburg, PA, United States, 17325
Location
Richmond, VA, United States, 23230
Location
Tacoma, WA, United States, 98405
Location
Philadelphia, PA, United States, 19104
Location
Lille, France, 59037
Location
Toulouse, France, 31059
Arms | Assigned Interventions |
---|---|
Experimental: Control Arm (Durvalumab monotherapy) durvalumab IV | Drug: Durvalumab Durvalumab Other Name: Durvalumab (MEDI-4736) |
Experimental: Arm A (durvalumab + oleclumab): durvalumab IV and oleclumab IV | Drug: Durvalumab + Oleclumab Durvalumab + Oleclumab Other Name: Durvalumab (MEDI-4736) Other Name: Oleclumab (MEDI-9447) |
Experimental: Arm B (durvalumab + monalizumab) durvalumab IV and monalizumab IV | Drug: Durvalumab + Monalizumab Durvalumab + Monalizumab Other Name: Durvalumab (MEDI-4736) Other Name: Monalizumab (IPH2201) |
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