Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC - KUNLUN
Study identifier:D910SC00001
ClinicalTrials.gov identifier:NCT04550260
EudraCT identifier:2020-001001-22
CTIS identifier:N/A
Recruitment Complete
Official Title
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)
Medical condition
Esophageal Squamous Cell Carcinoma
Phase
Phase 3
Healthy volunteers
No
Study drug
Durvalumab, Placebo, cisplatin + fluorouracil, cisplatin + capecitabine
Sex
All
Actual Enrollment
640
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 19 Oct 2020
Estimated Primary Completion Date: 28 Nov 2025
Estimated Study Completion Date: 30 Nov 2026
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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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 |
Contacts
Investigators
Principal Investigator
Luhua Wang
Cancer Hospital of Chinese Academy of Medical Science
