This is a prospective interventional study clinical study to investigate the efficacy and resistance mechanisms of intrathecal pemetrexed in patients with driver gene mutations advanced NSCLC with leptomeningeal metastases.
This is a prospective interventional clinical study aimed at investigating the efficacy and resistance mechanisms of intrathecal pemetrexed in advanced NSCLC patients with EGFR, ALK, and ROS1 mutations presenting leptomeningeal metastases. Approximately 30 advanced NSCLC patients with EGFR, ALK, and ROS1 mutations, who have developed leptomeningeal metastases following TKI resistance, will receive intrathecal pemetrexed. Cerebrospinal fluid samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms and differences. Second-generation gene detection will be performed to identify potential resistance mechanisms to pemetrexed. The study is expected to commence recruitment in mainland China around April 2024, with an anticipated completion date in April 2025.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease.
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGIntracranial progression-free survival (I-PFS)
Intracranial progression-free survival was defined as the duration from the start of IP to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death
Time frame: Time from first subject dose to study completion, or up to 36 month
System progression-free survival (s-PFS)
System progression-free survival was defined as the duration from the start of IP to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death
Time frame: Time from first subject dose to study completion, or up to 36 month
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