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

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Esophagogastric Junction; Gastrointestinal Neoplasms

Treatments: Drug: Durvalumab; Drug: FLOT chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04592913

2019-001555-40 (EudraCT Number)

D910GC00001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 957 patients

Sex: All

Ages: 18 to 200 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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957 participants in 2 patient groups, including a placebo group

Arm B

Placebo Comparator group

Description:

placebo product and FLOT chemotherapy

Treatment:

Drug: FLOT chemotherapy

Arm A

Experimental group

Description:

Durvalumab and FLOT chemotherapy

Treatment:

Drug: FLOT chemotherapy

Drug: Durvalumab