CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 547 enrolled
Drug / intervention
Bemarituzumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05052801
NCT05052801Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Sep 22, 2021·Updated May 27, 2026

In Brief

A Phase 3 clinical trial evaluating Bemarituzumab, mFOLFOX6, and 1 other intervention for Gastric Cancer and Gastroesophageal Junction Adenocarcinoma. Completed, enrolled 547 participants across 300 sites in 37 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Gastroesophageal Junction Adenocarcinoma
CountriesArgentina, 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), United States
CollaboratorsZai Lab (China only)

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedSep 22, 2021
Enrollment StartMar 7, 2022
Primary CompletionJun 20, 2025
Study CompletionApr 26, 2026
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 4.8 years ago

Interventions

Bemarituzumabdrug

Intravenous (IV) infusion

mFOLFOX6drug

mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Placebodrug

IV infusion