OncoMatch/Clinical Trials/NCT06109467
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
Is NCT06109467 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for gastroesophageal cancer.
Treatment: Neratinib · Trastuzumab · Oxaliplatin · 5-Fluorouracil + leucovorin · Pembrolizumab — The purpose of the study is to test the effects, both good and bad, of the research study drug Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy. This study will also look at the safety of Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX in HER2 overexpressing Gastroesophageal cancers.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) amplification (fish+ as defined as her2:cep17 ratio ≥2.0 if ihc 2+)
Required: HER2 (ERBB2) overexpression (ihc 3+)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant therapy allowed if >6 months since completion; maintenance nivolumab allowed if >3 months since last dose
Has had prior chemotherapy, targeted small molecule therapy, immunotherapy prior to study Day 1 for metastatic disease
Cannot have received: targeted small molecule therapy
Exception: adjuvant therapy allowed if >6 months since completion
Has had prior chemotherapy, targeted small molecule therapy, immunotherapy prior to study Day 1 for metastatic disease
Cannot have received: immunotherapy
Exception: maintenance nivolumab allowed if >3 months since last dose
Has had prior chemotherapy, targeted small molecule therapy, immunotherapy prior to study Day 1 for metastatic disease
Lab requirements
Blood counts
Demonstrate adequate organ function as outlined in protocol.
Kidney function
Demonstrate adequate organ function as outlined in protocol.
Liver function
Demonstrate adequate organ function as outlined in protocol.
Cardiac function
Must not have active decompensated cardiomyopathy and must have a normal LVEF (≥ 53%). If a patient has a borderline LVEF (40-52%), they may be considered after consultation with cardiology and study PI.
Demonstrate adequate organ function as outlined in protocol. Must not have active decompensated cardiomyopathy and must have a normal LVEF (≥ 53%). If a patient has a borderline LVEF (40-52%), they may be considered after consultation with cardiology and study PI.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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