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

NCT06525246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

ONO-7475

Specified dose, once daily

DRUG

Osimertinib Mesylate

Specified dose, once daily

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2025-06-23
Completion
2025-06-23

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06525246 on ClinicalTrials.gov