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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Male or female aged between 18 and 75 years.

Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations.

Cytologically confirmed diagnosis of leptomeningeal metastasis.

Normal organ function.

Disqualifiers

Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.

Any evidence of extensive and lethal progressive systemic diseases without effective treatment.

Patients with poor compliance or other reasons that were unsuitable for this study

Trial design

Treatments tested in this trial

  • pemetrexed
  • vometinib

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators