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

Phase 3Active Not RecruitingNCT04592913

AstraZeneca957 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

957

Conditions

Gastrointestinal Neoplasms Esophagogastric Junction

Interventions

DurvalumabDRUG

Human monoclonal antibody

FLOT chemotherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 200 Years

Medical Language ↔ Plain English

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.

Locations (156)

Outcomes

Primary Outcomes

Event-free survival (EFS)

EFS is the time from date of randomization until the date of disease progression or death.

Time frame: Up to 5 years

Secondary Outcomes

To compare Arm A relative to Arm B on overall survival (OS)

Overall survival is length of time from randomization until the date of death due to any cause.

Time frame: Up to 5 years

To compare Arm A relative to Arm B on pathological complete response (pCR) rate

pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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Research Site

Duarte, California, United States

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Sylmar, California, United States

Research Site

St. Petersburg, Florida, United States

Research Site

Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

Research Site

Fort Wayne, Indiana, United States

Research Site

Louisville, Kentucky, United States

Research Site

Boston, Massachusetts, United States

...and 146 more locations