臨床研究等提出・公開システム

Date of registration	July. 02, 2021
Last modified on	Mar. 13, 2026
Trial ID	jRCT2051210045

Scientific Title	ONO-7475-03: ONO-7475 Phase I Study An open-label, uncontrolled study of ONO-7475 in combination with osimertinib in EGFR gene mutation-positive non-small cell lung cancer
Public Title	ONO-7475-03 : ONO-7475 Phase 1 Study

Contact for Scientific Queries	Name	Hirashima Yoshinori
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Telephone	+81-120278120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Telephone	+81-120278120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Complete

Anticipated date of first enrollment		July. 15, 2021
Actual date of first enrollment		Aug. 06, 2021
Target sample size		75
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	1. Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation 2. Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib 3. Patient has an ECOG performance status of 0-1
	Exclusion Criteria	1. Patients with severe complication 2. Patients with multiple primary cancers
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		EGFR mutated, stage IIIB/IIIC/IV or recurrent, NSCLC, which is unsuitable for radical irradiation
Intervention(s)		Administration of ONO-7475 with Osimertinib
Primary Outcome(s)		Tolerability, safety

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Institutional Review Board of University Hopsital Kyoto Prefectural University of Medicine
Address	465 Kajiicho, Kawaramachi-dori Hirokoji agaru, Kamigyo-ku, Kyoto City, Kyoto
Telephone	+81-75-251-5873
Approval Status	Approval
Date of approval	June. 10, 2021

Plan to share IPD	No

Secondary ID(s)	NCT06525246

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
11	Mar. 13, 2026	(this page)	Changes
10	June. 10, 2025	Detail	Changes
9	Nov. 15, 2024	Detail	Changes
8	Oct. 08, 2024	Detail	Changes
7	Aug. 06, 2024	Detail	Changes
6	Nov. 07, 2022	Detail	Changes
5	Sept. 15, 2022	Detail	Changes
4	Dec. 18, 2021	Detail	Changes
3	Nov. 09, 2021	Detail	Changes
2	Sept. 22, 2021	Detail	Changes
1	July. 02, 2021	Detail

List of change history