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.
1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histopathology confirmed Non-small cell lung cancer.
4. confirmed or probable leptomeningeal metastases according to EANO-ESMO guidelines or known leptomeningeal metastases progression after third generation of EGFR-TKIs failure.
1. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.
2. Subjects who have received any of the following treatments must be excluded: Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
3. Presence of spinal cord compression.
4. History of other malignant tumors within 2 years.
Single group
Intrathecal Pemetrexed and high-dose Furmonertinib plus bevacizumab
Drug* 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.
LM-overall survival
LM-OS was defined as the duration from the start of intrathecal pemetrexed to patient death
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
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
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
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