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

• Status: Recruiting
• Trial end date: 2025-02-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab

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.