Study identifier:D910GC00001
ClinicalTrials.gov identifier:NCT04592913
EudraCT identifier:2019-001555-40
CTIS identifier:2023-507338-26-00
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)
Gastrointestinal Neoplasms
Phase 3
No
Durvalumab, FLOT chemotherapy
All
957
Interventional
18 Years - 200 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Arm B placebo product and FLOT chemotherapy | Drug: FLOT chemotherapy A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel |
Experimental: Arm A Durvalumab and FLOT chemotherapy | Drug: Durvalumab Human monoclonal antibody Drug: FLOT chemotherapy A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel |