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

Trial Status: Active

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).

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.

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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Yelena Y. Janjigian
Phone: 212-639-3113

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D910GC00001
  • Secondary IDs NCI-2021-01109, 2019-001555-40
  • Clinicaltrials.gov ID NCT04592913