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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)

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

Nakaji Masato

Nippon Kayaku Co., Ltd.

31-12, Shimo 3-Chome, Kita-ku, Tokyo

por01study@nipponkayaku.co.jp

Hirano Toshihiko

Nippon Kayaku Co., Ltd.

31-12, Shimo 3-Chome, Kita-ku, Tokyo

+81-3-6627-9722

por01study@nipponkayaku.co.jp

Recruiting

Feb. 24, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

< 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

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

Both

Esophageal cancer with EGFR amplification: Esophageal cancer cohort

Necitumumab intravenous infusion

D004938

D007262

Overall response rate

No

none