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

Sponsor
Jiangsu Province Nanjing Brain Hospital
Study ID
NCT06339242
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Furmonertinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Mar 2024
Primary completion
Jul 1, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Patients who met the inclusion criteria were given Furmonertinib tablets 160mg daily for continuous oral administration, and combined with Ommaya capsule technology lateral ventricle chemotherapy for local treatment until the disease progression of meningeal metastases or intolerance or death.

Primary Outcome Measure

LM-PFS（progression-free survival） [ Time Frame: Up to 2 years ]

Central Contacts

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