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 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria