RecruitingPhase 2NCT06339242

A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis

A Single-arm, Prospective Clinical Study of Double Dose of Furmonertinib Combined With Lateral Ventricular Chemotherapy in the Treatment of EGFR-mutant Lung Cancer With Leptomeningeal Metastasis After Third-generation EGFR-TKIs Resistance


Sponsor

Jiangsu Province Nanjing Brain Hospital

Enrollment

30 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Leptomeningeal metastasis is a fatal complication of advanced lung cancer. There is no standard treatment for leptomeningeal metastasis after third-generation EGFR-TKIs. The Furmonertinib prototype persists longer in brain tissue, and its metabolites can also penetrate the blood-brain barrier. Ommaya cystlateral ventricle chemotherapy can quickly control the progression of intracranial lesions. The aim of this study is to evaluate the LM progression-free survival (LM-PFS) of Furmonertinib combined with lateral ventricular chemotherapy in the treatment of leptomeningeal metastatic NSCLC after third-generation EGFR-TKIs resistance.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining furmonertinib (a targeted lung cancer drug) with chemotherapy can help patients with non-small cell lung cancer (NSCLC) that has spread to the lining of the brain and spine (leptomeningeal metastasis) — a particularly difficult-to-treat complication. **You may be eligible if...** - You are 18 to 75 years old - You have NSCLC with a specific genetic mutation (EGFR exon 19 deletion or exon 21 L858R mutation), confirmed by biopsy - Cancer has spread to the leptomeninges (the coverings of the brain and spine), confirmed by MRI or spinal fluid testing - Your cancer became resistant to third-generation EGFR-targeted therapies - Your overall health status (ECOG PS) is 0–3 - Expected survival of at least 12 weeks **You may NOT be eligible if...** - You have a cancer type other than lung cancer - You have unresolved significant side effects from prior treatment - You have uncontrolled nausea, vomiting, or severe GI conditions - You have significant liver or kidney problems - You are pregnant (termination strongly advised if pregnancy occurs during the study) 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

After completion of all screening activities, eligible patients were confirmed to enter the study. All patients will receive study treatment, Furmonertinib tablets 160mg, oral, once daily, lateral ventricular chemotherapy with Ommaya capsule technique until disease progression, intolerable toxicity, death, withdrawal of informed consent.


Locations(1)

Nanjing Brain Hospital

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06339242


Related Trials