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

Launched by BRITISH COLUMBIA CANCER AGENCY · Feb 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying patients with a type of lung cancer called EGFR mutant non-small cell lung cancer (NSCLC) that has spread to the protective layers around the brain and spinal cord, a condition known as leptomeningeal disease. The goal is to understand if there are differences in the cancer's genetic makeup when found in the spinal fluid compared to the blood. By comparing these two samples, researchers hope to find better ways to target treatments that could improve outcomes for patients.

To participate in this trial, you need to be at least 18 years old, have a confirmed diagnosis of metastatic EGFR mutant NSCLC, and have leptomeningeal disease as shown by a brain scan or analysis of spinal fluid. You should also be able to give informed consent and have a reasonable life expectancy. Participants will undergo tests that include a procedure called a lumbar puncture to collect spinal fluid, which is generally safe but may not be possible for everyone. This study is currently recruiting participants, so if you or a loved one meet the criteria, it could be an opportunity to contribute to important research while receiving care.

Gender

ALL

Eligibility 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.