臨床研究等提出・公開システム

Date of registration	Feb. 05, 2021
Last modified on	Dec. 24, 2024
Trial ID	jRCT2031200346

Scientific Title	ONO-4578-05:Phase 1 study of ONO-4578 given as combinations of ONO-4578, ONO-4538, docetaxel and ramucirumab in subjects with metastatic non-small cell lung cancer who have had disease progression during or after one prior first-line anti-PD-(L) 1 antibody and platinum-based chemotherapy for advanced/metastatic disease
Public Title	ONO-4578-05:ONO-4578 Phase 1 Study

Contact for Scientific Queries	Name	Hirashima Yoshinori
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120626190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Medical Information Center
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120626190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 12, 2021
Actual date of first enrollment		June. 01, 2021
Target sample size		40
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer 2. Life expectancy of at least 3 months 3. Patients with ECOG performance status 0 or 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		Non-small cell lung cancer
Intervention(s)		ONO-4578 given as combinations of ONO-4578, ONO-4538, docetaxel and ramucirumab
Primary Outcome(s)		Safety, tolerability

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Approval Status	Approval
Date of approval	Feb. 01, 2021

Plan to share IPD	No

Secondary ID(s)	NCT06542731

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
9	Dec. 24, 2024	(this page)	Changes
8	Nov. 15, 2024	Detail	Changes
7	Aug. 06, 2024	Detail	Changes
6	June. 24, 2023	Detail	Changes
5	May. 25, 2022	Detail	Changes
4	Nov. 09, 2021	Detail	Changes
3	June. 29, 2021	Detail	Changes
2	Mar. 31, 2021	Detail	Changes
1	Feb. 05, 2021	Detail

List of change history