NCT06339242

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu Province Nanjing Brain Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At present, there is still a lack of prospective, randomized clinical trials on the treatment of LM, most of which are small sample studies, retrospective analysis and clinical experience, with low level of evidence and limited clinical guidance. Improving the clinical outcome of patients with LM has become an urgent problem to be solved in clinical treatment. Our previous team has reported for the first time that Furmonertinib combined with lateral ventricular chemotherapy can not only effectively improve the neurological symptoms caused by LM, but also prolong the survival time of patients with limited and controllable side effects, which provides a new treatment approach for EGFR mutation-positive NSCLC accompanied by LM. Therefore, based on the structural and pharmacological differences between the three generations of EGFR-TKIs, combined with Ommaya lateral ventricle chemotherapy can rapidly control the progression of intracranial lesions, The aim of this study is to explore whether double dose of Furmonertinib combined with Ommya intracapsular ventricle chemotherapy can provide survival benefits for advanced EGFR mutation-positive NSCLC with leptomeningeal metastasis after third-generation EGFR-Tkis.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Furmonertinib	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-07-01
• Completion: 2026-01-31
• First posted: 2024-04-01
• Last updated: 2024-04-01

Locations

1 site across 1 country: China