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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04592913
Enrollment
957
Registered
2020-10-19
Start date
2020-11-17
Completion date
2027-09-27
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms, Esophagogastric Junction

Brief 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.

Interventions

DRUGDurvalumab

Human monoclonal antibody

DRUGFLOT chemotherapy

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized, Double-blind, Placebo-controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to 200 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
To compare Arm A relative to Arm B on overall survival (OS)Up to 5 yearsOverall survival is length of time from randomization until the date of death due to any cause.
To compare Arm A relative to Arm B on pathological complete response (pCR) rateUp to 5 yearspCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026