A Phase 2 Study of Necitumumab in Patients with Unresectable, Advanced or Recurrent Esophageal Cancer or Gastric Cancer with EGFR Amplification (NEO-GEAR Study)

Recruiting

• Conditions: Esophageal cancer with EGFR amplification: Esophageal cancer cohort

• Registration Number: jRCT2031240655
• Lead Sponsor: Nippon Kayaku Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-18
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

< Common >

• 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 < Esophageal cancer cohort >
• Histologically or cytologically diagnosed with unresectable advanced or recurrent esophageal cancer
• Refractory or intolerant to at least two regimens for esophageal cancer

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Overall response rate