Clinical trial · Interventional
Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Leptomeningeal Metastases
Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Meningeal Metastases: a One-arm, Phase II Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastases | Meningeal Carcinomatosis | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
| vometinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intrathecal injection of pemetrexed and double dose of vometinib
- interventionNames
- Drug: pemetrexed
- Drug: vometinib
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From the enrollment of this study until date of death from any cause, up to a maximum of approximately 2 years
- description
- Overall survival is the time from the date of enrollment of this study to death due to any cause.
Secondary outcomes (5)
- measure
- Impact on quality of life
- timeFrame
- From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged between 18 and 75 years. 2. Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations. 3. Cytologically confirmed diagnosis of leptomeningeal metastasis. 4. Normal organ function. 5. No history of severe nervous system disease. 6. No severe dyscrasia. Exclusion Criteria: 1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. 2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. Patients with poor compliance or other reasons that were unsuitable for this study
References
Publications (0)
Data not yet available