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)
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
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
- Secondary Outcome Measures
Name Time Method