RecruitingPhase 2NCT07304739

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

30 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination treatment for people with advanced lung cancer that has spread to the brain — specifically combining a targeted drug (furmonertinib), chemotherapy injected directly into the fluid around the spine (intrathecal chemotherapy), and focused radiation (stereotactic radiotherapy). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with lung adenocarcinoma (a type of non-small cell lung cancer) that is advanced or metastatic - Your tumor has a specific genetic mutation called EGFR (either 19Del or L858R) - Your cancer has spread to both the brain tissue and the lining around the brain (leptomeningeal metastases) - You have not received prior systemic cancer treatment **You may NOT be eligible if...** - You do not have the specific EGFR mutation - You have already received systemic anti-cancer treatment - You have poor overall health or organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFurmonertinib

Furmonertinib: 160mg, once daily, orally.

DRUGIntrathecal chemotherapy

Intrathecal chemotherapy with 40mg of pemetrexed and 2mg of dexamethasone, every 3 weeks as one cycle.

RADIATIONStereotactic 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.


Locations(3)

CANGZHOU People's Hospital

Cangzhou, Hebei, China

Tianjin medical university cancer hospital and institute

Tianjin, Tianjin Municipality, China

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07304739