Leptomeningeal Metastasis
Conditions
Interventions
Experimental group:Pemetrexed 15 mg, plus dexamethasone 5 mg, twice a week for 2 weeks as an induction phase, followed by once a week for 4 weeks as a consolidation phase. Thereafter, the maintenance
Sponsors
The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 18 and 75 years. 2. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del). 3. Confirmed diagnosis of leptomeningeal metastasis according to ESMO/ EANO guidelines. 4. Progression after previous double doses of third-generation TKIs such as Osimertinib. 5. Normal liver and kidney function; WBC=4000/mm3, Plt=100000/mm3. 6. No history of severe nervous system disease. 7. No severe dyscrasia.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate;Neurological progression-free survival (NPFS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Incidence of treatment-related adverse events ; | — |
Countries
China
Contacts
Public ContactZhenyu Pan
Huizhou Hospital of Guangzhou Medical University
Outcome results
None listed