NCT06525246

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ONO-7475	Specified dose, once daily
DRUG	Osimertinib Mesylate	Specified dose, once daily

Timeline

• Start date: 2021-08-06
• Primary completion: 2025-06-23
• Completion: 2025-06-23
• First posted: 2024-07-29
• Last updated: 2026-03-13

Locations

13 sites across 1 country: Japan