Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Meningeal Metastases: a One-arm, Phase II Clinical Study

NCT06861218 Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Zhejiang Cancer Hospital
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	42
Start date	2025-04
Completion	2028-12

Conditions

• Leptomeningeal Metastases

Interventions

• pemetrexed
• vometinib

Primary outcomes

• Overall survival — From the enrollment of this study until date of death from any cause, up to a maximum of approximately 2 years
  Overall survival is the time from the date of enrollment of this study to death due to any cause.

Countries

China