Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
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
2 other identifiers
interventional
78
1 country
13
Brief Summary
This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2021
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2021
CompletedFirst Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2025
CompletedMarch 13, 2026
March 1, 2026
3.9 years
July 24, 2024
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
28 days
Adverse event (AE)
Up to 28 days after the last dose
Secondary Outcomes (13)
Pharmacokinetics (Cmax)
Up to 57 Days
Pharmacokinetics (Tmax)
Up to 57 Days
Pharmacokinetics (AUC)
Up to 57 Days
Pharmacokinetics (Ctrough)
Up to 57 Days
Objective Response Rate (ORR)
Through study completion, an average of 2 year
- +8 more secondary outcomes
Study Arms (1)
ONO-7475+Osimertinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
- Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
- Patient has an ECOG performance status of 0-1
You may not qualify if:
- Patients with severe complication
- Patients with multiple primary cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Hyogo College Of Medicine College Hospital
Nishinomiya, Hyōgo, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Saitama Cancer Center
Ina, Kitaadati-gun, Saitama, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Nigata Cancer Center Hospital
Niigata, Niigata, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Sunto-gun, Shizuoka, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2024
First Posted
July 29, 2024
Study Start
August 6, 2021
Primary Completion
June 23, 2025
Study Completion
June 23, 2025
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share