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

NCT04592913 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2020-11-17

Last updated

2025-12-24

Condition(s) studied

Gastrointestinal NeoplasmsEsophagogastric Junction

Investigational drug(s) / intervention(s)

DurvalumabFLOT chemotherapy

Durvalumab: Human monoclonal antibody

FLOT chemotherapy: A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

200 Years

Healthy volunteers

Key Inclusion Criteria: * Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition). * Patients must undergo radical surgery. * No prior anti-cancer therapy for the current malignancy. * World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment. * Adequate organ and marrow function. * Availability of tumor sample prior to study entry. * Must have a life expectancy of at least 24 weeks. Key Exclusion Criteria: * Patients with peritoneal dissemination or distant metastasis. * Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. * Contra-indication to any of the study drugs. * History of allogeneic organ transplantation.

Primary outcome measure(s)

Event-free survival (EFS) — Up to 5 years
EFS is the time from date of randomization until the date of disease progression or death.

Trial sites (156)

Facility	City	Region
Research Site	Duarte	California
Research Site	Los Angeles	California
Research Site	Los Angeles	California
Research Site	Sylmar	California
Research Site	St. Petersburg	Florida
Research Site	Tallahassee	Florida
Research Site	West Palm Beach	Florida
Research Site	Fort Wayne	Indiana
Research Site	Louisville	Kentucky
Research Site	Boston	Massachusetts
Research Site	New York	New York
Research Site	Rochester	New York
Research Site	Nashville	Tennessee
Research Site	Dallas	Texas
Research Site	Lancaster	Texas
Research Site	Seattle	Washington
Research Site	Buenos Aires	Argentina
Research Site	Ciudad Autonoma Buenos Aires	Argentina
Research Site	Ciudad de Buenos Aires	Argentina
Research Site	Ciudad de Buenos Aires	Argentina
Research Site	Rosario	Argentina
Research Site	Rosario	Argentina
Research Site	Charleroi	Belgium
Research Site	Edegem	Belgium
Research Site	Leuven	Belgium
Research Site	Liège	Belgium
Research Site	Roeselare	Belgium
Research Site	Barretos	Brazil
Research Site	Natal	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Rio de Janeiro	Brazil
Research Site	São José do Rio Preto	Brazil
Research Site	São Paulo	Brazil
Research Site	Edmonton	Alberta
Research Site	North York	Ontario
Research Site	Oshawa	Ontario
Research Site	Toronto	Ontario
Research Site	Montreal	Quebec
Research Site	Montreal	Canada

+ 116 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04592913 on ClinicalTrials.gov ↗ ← All trials in the UK