A Phase 2 Study of Necitumumab in Patients with Unresectable, Advanced or Recurrent Esophageal Cancer or Gastric Cancer with EGFR Amplification

A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy and Safety of Necitumumab in Patients with Unresectable, Advanced or Recurrent Esophageal Cancer or Gastric Cancer with EGFR Amplification - NEO-GEAR Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240655

Enrollment

Registered

2025-02-18

Start date

2025-06-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer with EGFR amplification / Gastric cancer with EGFR amplification

Interventions

Necitumumab intravenous infusion

D007262

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - EGFR amplification determined to be positive by a tissue or blood test at the time of informed consent - EGFR copy number confirmed to be at or above the threshold for determination of EGFR amplification by Guardant360 CDx using the blood sample performed after informed consent was obtained - Having measurable lesions as per RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 - Histologically or cytologically diagnosed with unresectable advanced or recurrent esophageal cancer - Refractory or intolerant to at least two regimens for esophageal cancer - Histologically or cytologically diagnosed with unresectable advanced or recurrent gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) - Refractory or intolerant to at least three regimens for gastric cancer

Exclusion criteria

Exclusion criteria: - Multiple active cancers - Symptomatic central nervous system (brain, spinal cord, or meninges) metastases - Previous treatment with EGFR inhibitors or anti-EGFR antibodies - HER2 positive

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Contacts

Public ContactToshihiko Hirano

Nippon Kayaku Co., Ltd.

por01study@nipponkayaku.co.jp+81-3-6627-9722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026