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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

December 31, 2028

Conditions
Leptomeningeal Metastases
Interventions
DRUG

pemetrexed

The pemetrexed is administrated by intrathecal injection with a dose of 50mg, once per week for 4 weeks, followed by every four weeks thereafter. The cerebrospinal fluid(CSF) samples are collected every 4 weeks and the cytology examination will be performed. If CSF cytology was negative, CSF cytology was tested again 1 week later. Two negative tests were considered as negative CSF cytology. If the cytology of cerebrospinal fluid was negative after 4 consecutive intrathecal injections, the intrathecal injection should be stopped. If positive, continue to give a intrathecal injection every 4 weeks until CSF cytology is negative. If CSF cytological positivity or worsening of neurological symptoms occurs again during discontinuation, or if new symptoms appear, the intrathecal injection should be resumed every 4 weeks.

DRUG

vometinib

double dose of vometinib (160mg)

Trial Locations (1)

Unknown

Zhejiang Cancer Hospital, Hangzhou

All Listed Sponsors
lead

Zhejiang Cancer Hospital

OTHER