Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC (NCT05813522) | Clinical Trial Compass
UnknownPhase 2
Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC
China30 participantsStarted 2022-04-15
Plain-language summary
The goal of this clinical trial is to evaluate the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation. Participants will be treated with 160mg Furmonertinib daily and tumor evaluation will be performed every 6-8 weeks. The participants' blood and cerebrospinal fluid samples will be collected three times during the study for ctDNA detection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.
. Age ≥18 years.
. Newly diagnosed NSCLC patients with leptomeningeal metastases associated with EGFR activating mutant or patients who develop leptomeningeal metastases only after treatment with first- or second-generation of EGFR-TKIs.
. LM diagnosis was based on the detection of malignant cells in the CSF. Patients with new neurological symptoms and signs or typical MRI findings, together with the EGFR mutations detected by CSF ctDNA, can also be enrolled even if CSF cytology is not positive.
. Subjects may be eligible for or have had CNS shunt or Ommaya fluid reservoir implantation. Patients who do not meet the requirements should be able to cooperate with lumbar puncture.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intracranial Progression-Free Survival (PFSi)
Timeframe: Assessed up to 12 months.
2
Overall Progression-Free Survival (PFSo)
Timeframe: Assessed up to 12 months.
Trial details
NCT IDNCT05813522
SponsorFirst Affiliated Hospital of Zhejiang University
. Patients must have stable extracranial symptoms and have no CNS complications requiring urgent neurosurgical intervention for at least 4 weeks before study enrollment.
Exclusion criteria
. Previous or current treatment of any third-generation EGFR-TKI.
. Previously treated with radiotherapy for central nervous system metastases.
. A history of stroke within 6 months or pre-existing central nervous system damage which can interfere with neurological evaluation.
. A history of chronic gastrointestinal disease or any other medical condition that would preclude adequate absorption of Furmonertinib.
. Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of Furmonertinib) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A4/5.
. A history of previous or current tumors other than NSCLC, with the exception of radical non-melanoma skin cancer, carcinoma in situ of the cervix, benign prostate tumor/hypertrophy, or other cancers that have been radical and have no evidence of relapse for at least 5 years.
. Past medical history of any kinds of interstitial lung disease or radiation pneumonitis.
. Systemic antitumor therapy with other agents was planned before enrollment or during the duration of the study.