Study identifier:D9078C00001
ClinicalTrials.gov identifier:NCT05221840
EudraCT identifier:2021-004346-37
CTIS identifier:N/A
A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy
Non-small Cell Lung Cancer
Phase 3
No
Durvalumab, Oleclumab, Monalizumab
All
999
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm A: Durvalumab and Oleclumab Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months | Drug: Durvalumab Durvalumab IV (intravenous infusion) Drug: Oleclumab Oleclumab IV (intravenous infusion) |
Experimental: Arm B: Durvalumab and Monalizumab Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only | Drug: Durvalumab Durvalumab IV (intravenous infusion) Drug: Monalizumab Monalizumab IV (intravenous infusion) Other: Placebo Placebo IV (intravenous infusion) |
Active Comparator: Arm C: Durvalumab and Placebo Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other: Placebo Placebo IV (intravenous infusion) |