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New treatment option for EGFR Activating Mutation
Official title CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease
ClinicalTrials.gov ID: NCT05257967
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
- people 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.
See the full eligibility 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.
- Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.