Study identifier:D910SC00001
ClinicalTrials.gov identifier:NCT04550260
EudraCT identifier:2020-001001-22
CTIS identifier:N/A
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
Esophageal Squamous Cell Carcinoma
Phase 3
No
Durvalumab, Placebo, cisplatin + fluorouracil, cisplatin + capecitabine
All
640
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: Durvalumab + definitive CRT Durvalumab + concurrent chemoradiation | Drug: Durvalumab Durvalumab intravenous infusion Other Name: MEDI4736 Drug: cisplatin + fluorouracil cisplatin + fluorouracil, as per Standard of Care Drug: cisplatin + capecitabine cisplatin + capecitabine, as per Standard of Care Radiation: Radiation 50-64Gy in total |
Placebo Comparator: Arm 2: Placebo + definitive CRT Placebo + concurrent chemoradiation | Drug: Placebo Durvalumab matching placebo for intravenous infusion Drug: cisplatin + fluorouracil cisplatin + fluorouracil, as per Standard of Care Drug: cisplatin + capecitabine cisplatin + capecitabine, as per Standard of Care Radiation: Radiation 50-64Gy in total |