This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs.
This prospective interventional study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant NSCLC patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs. Approximately 30 EGFR-mutant Non-small cell lung cancer patients with leptomeningeal metastasis or leptomeningeal progression after resistant to third generation EGFR-TKIs were enrolled and treated with intrathecal pemetrexed with high-dose furmonertinib plus bevacizumab. cerebrospinal fluid and blood samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms. Second-generation gene detection will be performed to identify potential resistance mechanisms to pemetrexed. The study is expected to commence recruitment in mainland China in about August 2024. It is expected that the trial will end in April 2026.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
* Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly; * Furmonertinib(160mg QD); * bevacizumab(5mg/kg,once monthly) until progressive disease.
Hunan Cancer Hospital
Changsha, Hunan, China
LM-overall survival
LM-OS was defined as the duration from the start of intrathecal pemetrexed to patient death
Time frame: Time from first subject dose to study completion, or up to last follow up
Extracranial progression-free survival
Extracranial Progression-Free survival was defined as the duration from the start of intrathecal pemetrexed to the progression of extracranial disease or patient death or last follow up
Time frame: Time from first dose to the progression of extracranial disease or patient death or last follow up
Clinical response rate
Clinical Response Rate was defined as the ratio of the patient whose neurological symptoms and KPS improved according to the criteria of clinical response
Time frame: Time from first dose to the improvement of neurological symptoms and KPS score
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame: From first dose until 28 days after the last dose, up to 24 month
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