MATTERHORN: NCT04592913: Phase 3: Neoadjuvant FLOT +/- Durvalumab Followed by Adjuvant FLOT +/- Durvalumab in GC/GEJC
NCT04592913: Phase 3: (MATTERHORN): Neoadjuvant FLOT +/- Durvalumab Followed by Adjuvant FLOT +/- Durvalumab in GC/GEJC
ClinicalTrials.gov ID: NCT04592913 — MATTERHORN
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
Primary Publication: Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. Janjigian YY, Al-Batran SE, Wainberg ZA, et al.; MATTERHORN Investigators. New England Journal of Medicine. 2025;393:217–230.
Updated Overall Survival Publication: Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Janjigian YY, Al-Batran SE, Wainberg ZA, et al.; MATTERHORN Investigators. The Lancet. 2026;408(10560):1114–1128.
FDA Approval — YES; Approval Date: November 25, 2025FDA Announcement: FDA approved durvalumab (Imfinzi) with FLOT as neoadjuvant and adjuvant treatment, followed by single-agent durvalumab, for adults with resectable gastric or gastroesophageal-junction adenocarcinoma. MATTERHORN was the efficacy trial supporting the approval.
NCCN Supported — YES
NCCN Template
Imfinzi (durvalumab) — AstraZeneca