NCT07413952

Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases

Efficacy and Safety of Limertinib (ASK120067) Combined With Radiotherapy as First-Line Treatment in Patients With EGFR-Mutant Non-Small Cell Lung Cancer and Brain Metastases: A Single-Arm, Multicenter, Prospective Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with brain metastases remain a major clinical challenge. Although EGFR-TKIs have demonstrated intracranial activity, disease control is still suboptimal in some patients. Limertinib (ASK120067) is a novel third-generation EGFR tyrosine kinase inhibitor with favorable central nervous system penetration and encouraging intracranial antitumor activity. The potential synergistic effect of limertinib combined with radiotherapy warrants further investigation. This prospective, multicenter, single-arm phase II study aims to evaluate the efficacy and safety of first-line limertinib combined with radiotherapy in this patient population.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Limertinib Plus Radiotherapy	Limertinib Plus Radiotherapy

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China