Trial Profile

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 18 Jun 2025

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At a glance

Drugs Bemarituzumab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Nivolumab (Primary) ; Oxaliplatin (Primary)
Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms FORTITUDE-102
Sponsors Amgen

12 Jun 2025 Planned End Date changed from 26 Sep 2026 to 29 Jan 2027.
12 Jun 2025 Planned primary completion date changed from 26 Sep 2026 to 29 Jan 2026.
27 Feb 2025 According to Zai Lab media release, potential Biologics License Application (BLA) submission to NMPA in the first half of 2025.

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