drugset / Trial / NCT06861218

Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Leptomeningeal Metastases

NCT06861218 ↗

Phase 2 Not yet recruiting 42 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

With the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. High-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. However, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. In this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose EGFR-targeted drug in patients with leptomeningeal metastases from EGFR-positive NSCLC.

Timeline

Start
2025-04
Primary completion
2028-05
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pemetrexed Small molecule 50 mg Intrathecal
Subject vometinib Unknown 160 mg —

Indications