Status:
ACTIVE_NOT_RECRUITING
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Stage IIIB Non-small Cell Lung Cancer
Stage IIIC Non-Small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with severe complication
- Patients with multiple primary cancers
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06525246
Start Date
August 6 2021
End Date
April 30 2026
Last Update
June 12 2025
Active Locations (13)
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1
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
2
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
3
Hyogo College Of Medicine College Hospital
Nishinomiya, Hyōgo, Japan
4
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan