Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

Study identifier:D910GC00001

ClinicalTrials.gov identifier:NCT04592913

EudraCT identifier:2019-001555-40

CTIS identifier:2023-507338-26-00

Recruitment Complete

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)

Medical condition

Gastrointestinal Neoplasms

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, FLOT chemotherapy

Sex

All

Actual Enrollment

957

Study type

Interventional

Age

18 Years - 200 Years

Date

Study Start Date: 17 Nov 2020
Estimated Primary Completion Date: 31 Oct 2025
Estimated Study Completion Date: 27 Sept 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria