Actively Recruiting
Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-07-29
40
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptomeningeal metastases (LM) are a relatively rare site of metastasis in advanced non-small cell lung cancer (NSCLC), and LM patients have a poor prognosis. Numerous retrospective studies have reported that high-dose Firmonertinib can also effectively increase patient prognosis and have tolerable side effects, but there is a lack of prospective studies to confirm this. In addition, there are currently no good biomarkers for monitoring the efficacy of LM treatment. cfDNA testing can be used for early cancer screening, monitoring tumor progression, evaluating treatment response, and discovering drug resistance mechanisms. Due to the influence of the blood-brain barrier, the level of cfDNA in the plasma of LM patients is often very low, and the detection of cfDNA in cerebrospinal fluid (CSF) is more advantageous. Therefore, exploring the dynamic monitoring of LM treatment efficacy using CSF cfDNA is of great significance for improving patient prognosis. Based on this, the applicant intends to conduct a prospective, multicenter, single-arm, post-market exploratory clinical trial on the treatment methods and efficacy monitoring of NSCLC-LM patients. The aim was to explore whether cfDNA has the potential to become a biomarker for LM efficacy monitoring and to validate the efficacy and safety of high-dose fumatinib combined with intrathecal injection in the treatment of NSCLC-LM patients.
CONDITIONS
Official Title
Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by patient or legal representative
- Age 18 years or older
- Metastatic (stage IV) NSCLC confirmed by histology or cytology
- EGFR exon 19 deletion or exon 21 L858R mutation confirmed by central laboratory
- ECOG performance status 0-3 with expected survival of at least 12 weeks
- At least one measurable lesion according to RECIST 1.1
- Diagnosis of leptomeningeal metastases meeting EANO-ESMO criteria (type I or type II with EGFR mutation in CSF ctDNA); brain metastases allowed
- Progression after first-line treatment with first or second-generation EGFR-TKI
- Progression after first-line conventional dose third-generation EGFR-TKI
- Able and willing to undergo lumbar puncture, with no contraindications to chemotherapy or lumbar puncture
- Stable extracranial symptoms for at least 4 weeks prior to treatment, with no CNS complications requiring emergency neurosurgery
You will not qualify if you...
- Squamous cell carcinoma of the lung
- Known hypersensitivity to famotinib, pemetrexed, or related drugs
- Confirmed EGFR exon 20 insertion mutation
- Unresolved toxicities from prior anti-tumor treatments greater than CTCAE Grade 1 (except certain neurotoxicities)
- History of other malignant tumors within past 5 years except controlled skin basal cell carcinoma, cervical carcinoma in situ, or ductal breast carcinoma
- Deemed unable to comply with study requirements by researchers
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
P
Peng Ding, Dr
CONTACT
X
Xiaorong Dong, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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