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NCT Number: NCT05257967

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

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.

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Key information

Conditions

EGFR Activating Mutation Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Neoplasms Leptomeningeal Metastasis Lung Diseases Lung Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Cancer

Vancouver, British Columbia, V5Z4E6, Canada

Location status: Recruiting

Location contact

Cheryl Ho, MD

CONTACT

604-877-6000

About this study

The aim of this pilot trial is to evaluate the concordance/discordance of molecular profiling of CSF and plasma ctDNA after the development of leptomeningeal disease in EGFR mutant NSCLC. Patients with EGFR mutant NSCLC who develop leptomeningeal disease on a first, second or third generation tyrosine kinase inhibitor are potentially eligible for this clinical trial.

This is a prospective pilot study designed to accrue 10 patients. Baseline MRI brain and spine must be completed prior to enrolment to insure that a lumbar puncture can be completed safely. All eligible subjects will be consented for ddPCR and Canexia Follow It plasma and CSF based molecular testing. Patients will have baseline information collected and will complete baseline quality of life (QoL) questionnaires. QoL questionnaires will be obtained every 12 weeks +/- 2 weeks and survival will be measured through chart review. There will be no treatment intervention; however we will collect information on treatment received after enrolment in trial. Volume of leptomeningeal disease will be scored by number of gadolinium enhancing sites in 8 predetermined locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumbar puncture and Phlebotomy

Diagnostic Test

Sampling of cerebral spinal fluid and plasma.

Primary outcomes

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

    Time frame: 36 months

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

Secondary outcomes

  1. Concordance of treatment recommendations based on ctDNA and CSF

    Time frame: 36 months

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

  2. Molecular profiling comparison

    Time frame: 36 months

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

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

    Time frame: 36 months

    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

  4. Correlation between MRI and CSF

    Time frame: 36 months

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

  5. Overall survival

    Time frame: 36 months

    To determine overall survival from time of developing leptomeningeal disease.

  6. Quality of life with leptomeningeal disease

    Time frame: 36 months

    To assess the quality of life using the validated instrument, EuroQol 5 Dimension (EQ5D) (Scale of 0-100 where 0 is worst health and 100 is best health)

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Melosky, MD

CONTACT

604.877.6000

Cheryl Ho, MD

CONTACT

[email protected]

604.877.6000

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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