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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05257967
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	British Columbia Cancer Agency
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Cheryl Ho, MD
Principal Investigator Affiliation	BC Cancer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	EGFR Activating Mutation, Leptomeningeal Metastasis, Non Small Cell Lung Cancer

Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental arm

ddPCR and BC Cancer NGS panel completed on cerebral spinal fluid and blood circulating tumor DNA

Interventions

Diagnostic Test: - Lumbar puncture and Phlebotomy

Sampling of cerebral spinal fluid and plasma.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

BC Cancer, Vancouver 6173331, British Columbia 5909050, Canada

Status

Recruiting

Address

BC Cancer

Vancouver 6173331, British Columbia 5909050, V5Z4E6

Site Contact

Cheryl Ho, MD

[email protected]

604-877-6000

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