Study identifier:D933QC00001
ClinicalTrials.gov identifier:NCT03703297
EudraCT identifier:2018-000867-10
CTIS identifier:N/A
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
Small cell lung cancer
Phase 3
No
Durvalumab, Tremelimumab
All
730
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab + Placebo Durvalumab monotherapy: Durvalumab (1500 mg intravenous [IV]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution. | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Other: Placebo Placebo IV (intravenous infusion) |
Experimental: Durvalumab + Tremelimumab Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab. | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Drug: Tremelimumab Tremelimumab IV (intravenous infusion) |
Placebo Comparator: Placebo + Placebo Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination. | Other: Placebo Placebo IV (intravenous infusion) |