NCT04592913

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 957 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 200 Years
• Healthy volunteers: Not accepted

Summary

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

Detailed description

This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.

Conditions

• Gastrointestinal Neoplasms
• Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	Durvalumab	Human monoclonal antibody
DRUG	FLOT chemotherapy	A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Timeline

• Start date: 2020-11-17
• Primary completion: 2024-12-20
• Completion: 2027-09-27
• First posted: 2020-10-19
• Last updated: 2025-12-24

Locations

156 sites across 20 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Hungary, Japan, Netherlands, Peru, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study