Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT05257967
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05257967
Study Brief:
Protocol Section:
NCT05257967