Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT05813522
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to evaluate the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation. Participants will be treated with 160mg Furmonertinib daily and tumor evaluation will be performed every 6-8 weeks. The participants' blood and cerebrospinal fluid samples will be collected three times during the study for ctDNA detection.

Key Dates

Start date
Apr 15, 2022
Status verified
Apr 2023
Primary completion
Apr 30, 2025
Completion
Aug 31, 2025

Study Design

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

Arms

  • Experimental: Furmonertinib
    Furmonertinib 160mg po qd

Primary Outcome Measure

Intracranial Progression-Free Survival (PFSi) [ Time Frame: Assessed up to 12 months. ]

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