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CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease

ConditionsEGFR Activating MutationLeptomeningeal MetastasisNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lumbar puncture and Phlebotomy

    Diagnostic test

    Sampling of cerebral spinal fluid and plasma.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Concordance of molecular profiling of CSF and plasma in EGFR mutation positive NSCLC patients with leptomeningeal disease

To determine the concordance rate of molecular alterations detected in the CSF and plasma of EGFR mutation positive NSCLC patients with leptomeningeal disease

Time frame
36 months

Secondary outcomes

1

Concordance of treatment recommendations based on ctDNA and CSF

To determine the concordance and discordance between physician treatment recommendations based on ctDNA versus CSF molecular profiling.

Time frame
36 months
2

Molecular profiling comparison

To assess concordance/discordance rates between ddPCR and Canexia Follow It completed on CSF and plasma based testing.

Time frame
36 months
3

Molecular profiling descriptive comparison of patients treated with first/second generation versus 3rd generation EGFR TKIs

To identify molecular aberrations in the ctDNA and CSF of patients who progress on first/second EGFR TKIs and third generation EGFR TKIs to perform a descriptive comparison of shared and unique mutations identified based on prior exposure to first/second versus third generation EGFR TKI

Time frame
36 months
4

Correlation between MRI and CSF

To correlate burden of leptomeningeal disease found on MRI and CSF positivity for tumor DNA.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Source ClinicalTrials.gov
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