臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 18, 2025
Last modified on	Aug. 29, 2025
Trial ID	jRCT2031240655

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

Contact for Scientific Queries	Name	Nakaji Masato
	Affiliation	Nippon Kayaku Co., Ltd.
	Address	31-12, Shimo 3-Chome, Kita-ku, Tokyo
	Telephone	+81-3-6627-9722
	E-mail	por01study@nipponkayaku.co.jp
Contact for Public Queries	Name	Hirano Toshihiko
	Affiliation	Nippon Kayaku Co., Ltd.
	Address	31-12, Shimo 3-Chome, Kita-ku, Tokyo
	Telephone	+81-3-6627-9722
	E-mail	por01study@nipponkayaku.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 24, 2025
Actual date of first enrollment
Target sample size		34
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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 < Gastric cancer cohort > - 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	< Common > - Multiple active cancers - Symptomatic central nervous system (brain, spinal cord, or meninges) metastases - Previous treatment with EGFR inhibitors or anti-EGFR antibodies < Gastric cancer cohort > - HER2 positive
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Esophageal cancer with EGFR amplification / Gastric cancer with EGFR amplification
Intervention(s)		Necitumumab intravenous infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D004938, D013274
Intervention(s) Code		D007262
Primary Outcome(s)		Overall response rate
Secondary Outcome(s)

Primary Sponsor	Nippon Kayaku Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Saitama Prefectural Cancer Center Institutional Review Board
Address	780 Komuro, Ina-machi, Kitaadachi-gun, Saitama, Saitama
Telephone
E-Mail
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Aug. 29, 2025	(this page)	Changes
5	July. 28, 2025	Detail	Changes
4	June. 30, 2025	Detail	Changes
3	May. 30, 2025	Detail	Changes
2	April. 25, 2025	Detail	Changes
1	Feb. 18, 2025	Detail

List of change history