Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06525246
Phase
PHASE1
Status
Completed

Conditions

  • EGFR Mutation-Related Tumors
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IIIC Non-Small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 6, 2021
Status verified
Mar 2026
Primary completion
Jun 23, 2025
Completion
Jun 23, 2025

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-7475+Osimertinib

Primary Outcome Measure

Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） [ Time Frame: 28 days ]

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