NCT07304739

Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases

A Single-Arm Clinical Study of Furmonertinib (160mg) Combined With Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Single-Arm Clinical Study of Furmonertinib (160mg) Combined with Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients with Brain Parenchymal and Leptomeningeal Metastases

Detailed description

The incidence of central nervous system (CNS) metastases in NSCLC representing a primary cause of mortality. In recent years, the widespread use of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) has significantly prolonged survival in lung adenocarcinoma patients, consequently leading to increased incidence of brain metastases (BM) and leptomeningeal metastases (LM). Both BM and LM are associated with poor prognosis. Therefore, developing more effective treatment strategies for BM and LM patients has become a cutting-edge, challenging, and critically important research focus.This study aims to evaluate the efficacy and safety of Furmonertinib (160 mg) combined with intrathecal chemotherapy and stereotactic radiotherapy (SRT) in treatment-naïve EGFR-mutated NSCLC patients with concurrent parenchymal brain and leptomeningeal metastases. The objective is to explore potential survival benefits for this poor-prognosis population and provide additional clinical treatment options.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Furmonertinib	Furmonertinib: 160mg, once daily, orally.
DRUG	Intrathecal chemotherapy	Intrathecal chemotherapy with 40mg of pemetrexed and 2mg of dexamethasone, every 3 weeks as one cycle.
RADIATION	Stereotactic radiotherapy	After two cycles of intrathecal chemotherapy, there was no progression upon re-examination. The stereotactic radiotherapy (SRT) for brain metastases with 7-19Gy/1-5Fx.

Timeline

• Start date: 2025-12-22
• Primary completion: 2028-12-30
• Completion: 2029-12-30
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

3 sites across 1 country: China