NCT05052801

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Bemarituzumab	Intravenous (IV) infusion
DRUG	mFOLFOX6	mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
DRUG	Placebo	IV infusion

Timeline

• Start date: 2022-03-07
• Primary completion: 2025-06-20
• Completion: 2026-06-20
• First posted: 2021-09-22
• Last updated: 2026-02-19

Locations

300 sites across 37 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Estonia, France, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Norway, Peru, Poland, Portugal, Romania, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study