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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06440954
Study type Interventional
Source Hunan Province Tumor Hospital
Contact Zhang Yongchang, professor
Phone 13873123436
Email zhanglei1152@126.com
Status Recruiting
Phase Phase 2
Start date May 1, 2024
Completion date April 30, 2027

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