Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07304739
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Furmonertinib — DRUG
    Furmonertinib: 160mg, once daily, orally.
  • Intrathecal chemotherapy — DRUG
    Intrathecal chemotherapy with 40mg of pemetrexed and 2mg of dexamethasone, every 3 weeks as one cycle.
  • Stereotactic radiotherapy — RADIATION
    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.

Study Details

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

Key Dates

Start date
Dec 22, 2025
Status verified
May 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

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

Arms

  • Experimental: Furmonertinib combined with intrathecal chemotherapy and stereotactic radiotherapy group

Primary Outcome Measure

iPFS [ Time Frame: From enrollment to the occurrence of intracranial disease progression (excluding non-intracranial progression) or death，assessed up to 2 year ]

Central Contacts

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