Clinical trial · Interventional
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
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)
NCT04592913CI-TRIAL-00099660active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagogastric Junction | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| FLOT chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm B
- description
- placebo product and FLOT chemotherapy
- interventionNames
- Drug: FLOT chemotherapy
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Durvalumab and FLOT chemotherapy
- interventionNames
- Drug: Durvalumab
- Drug: FLOT chemotherapy
Primary outcomes (1)
- measure
- Event-free survival (EFS)
- timeFrame
- Up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 200 Years
Show eligibility criteria text
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.
References
Publications (4)
- DERIVEDJanjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, Tabernero J; MATTERHORN Investigators. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jul 17;393(3):217-230. doi: 10.1056/NEJMoa2503701. Epub 2025 Jun 1. PMID 40454643
- DERIVEDChang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. PMID 35623069
- DERIVEDJanjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10. PMID 35535555
- DERIVEDCowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available. PMID 35179774