CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease
Recruiting · NCT05257967 · Interventional (participants receive a specific treatment) · Lead sponsor: British Columbia Cancer Agency
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC. Systemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.
Who can take part
Inclusion criteria
- Subject age is greater than or equal to 18 years at the time of signature of informed consent.
- Histologically or cytologically confirmed metastatic EGFR mutant NSCLC.
- Leptomeningeal disease based on brain MRI or CSF cytology.
- ECOG 0-3.
- Life expectancy of at least 8 weeks.
- Adequate hematologic and end organ function for testing.
- Ability to give informed consent for the study procedures defined in this protocol.
Exclusion criteria
- Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
- Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
- MRI spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.
Where it is running
1 location listed.
- BC Cancer - Vancouver, British Columbia, Canada