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

Phase 3

Active, not recruiting

• Conditions: Gastrointestinal Neoplasms; Esophagogastric Junction
• Interventions: Drug: Durvalumab; Drug: FLOT chemotherapy

• Registration Number: NCT04592913
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Study Start: 2020-11-17
• Primary Completion: 2024-12-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Study Completion: 2027-09-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 958

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Durvalumab	Durvalumab and FLOT chemotherapy
Arm B	FLOT chemotherapy	placebo product and FLOT chemotherapy
Arm A	FLOT chemotherapy	Durvalumab and FLOT chemotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Surrey, United Kingdom