Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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.
EXCLUSION CRITERIA
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Gastrointestinal Neoplasms,Esophagogastric Junction
Age (in years)
18 - 200
Phase
Phase 3
Participants needed
958
Est. Completion Date
Feb 14, 2025
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT04592913
Study number
D910GC00001
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