Pulsed high-dose furmonertinib for EGFR lung cancer spread to the brain's lining
Tests furmonertinib in adults with EGFR lung cancer spread to the meninges.
Key facts
- Who runs it
- Guangzhou University of Traditional Chinese Medicine
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis
- Status
- Recruiting
- People taking part
- 42 people, planned
- Started
- 1 Mar 2026
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Furmonertinib 320mg qod po
- Furmonertinib 160mg qd po
- Record updated
- 2 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with EGFR-mutant non-small cell lung cancer that has spread to the membranes around the brain and spinal cord (leptomeningeal metastasis), and whose disease grew after first-line TKI treatment.
- Age
- 18 to 85 years in the inclusion criteria (the registry header lists a maximum age of 75 years)
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer confirmed by tissue or cell examination, with leptomeningeal metastasis confirmed by positive cerebrospinal fluid cytology within 28 days before the first dose. At least 1 lesion must be measurable repeatedly on MRI.
- Earlier treatment
- The disease must have progressed after first-line tyrosine kinase inhibitor (TKI) treatment. People joining the pharmacokinetic study must not have had furmonertinib before.
- Biomarker or test result
- EGFR exon 19 deletion or exon 21 L858R mutation.
Main reasons for not taking part
- Severe or uncontrolled illness, such as active infection, electrolyte problems or bleeding tendency
- Pregnant or breastfeeding women, or planned pregnancy during the study or within 6 months after it
- Central nervous system complications needing emergency neurosurgery
- Another cancer now or in the past
- Severe allergy, especially serious reactions to earlier TKI treatment
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patients with non-small cell lung cancer (NSCLC) confirmed by histopathological or cytopathological examination
- Patients with EGFR exon 19 deletion or exon 21 L858R mutation
- Patients with leptomeningeal metastasis (LMD) confirmed by positive cerebrospinal fluid (CSF) cytology (within 28 days prior to the first dose administration) and with at least 1 LMD lesion that can be repeatedly evaluated by magnetic resonance imaging (MRI)
- Patients with disease progression after first-line tyrosine kinase inhibitor (TKI) treatment
- Aged ≥18 years and ≤85 years, with no gender restrictions
- Sufficient organ function, defined as: absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 75×10⁹/L, hemoglobin ≥ 90g/L total bilirubin ≤ 1.5×upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, total bilirubin can be relaxed to ≤ 3×ULN, and ALT/AST can be relaxed to ≤ 5×ULN) serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula)
- For patients enrolled in the pharmacokinetic study: no prior treatment with furmonertinib (either in combination or as monotherapy)
- Patients who have signed the informed consent form, are willing to receive treatment under this protocol, can adhere to medication administration, and have good compliance
Who cannot take part
- Patients with a severe allergic diathesis, especially those who have experienced severe drug allergies or other serious adverse reactions during previous treatment with tyrosine kinase inhibitors (TKIs)
- Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc
- Suffering from other malignant tumors or having a history of other malignant tumors
- Complicated with severe brain diseases or mental illnesses that affect the patient's ability to report symptoms by themselves
- Unable to complete the baseline assessment form
- Pregnant or lactating women, or those with planned pregnancy during the study or within 6 months after the study ends
- Presence of central nervous system complications requiring emergency neurosurgical intervention
- Individuals without legal capacity, or those for whom medical or ethical reasons affect the continuation of the study
- Other circumstances deemed unsuitable for participation in this study by the researcher
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Guangdong Provincial Hospital of Chinese MedicineGuangzhou, ChinaContact: Yanjuan Zhu, M.D.Taking people
About the trial
What the trial wants to find out
The goal of this clinical trial is to clarify the efficacy and safety of the high-dose alternate-day furmonertinib in NSCLC with leptomeningeal metastasis. It will also explore the mechanism by which the high-dose alternate-day administration regimen enhances efficacy from a pharmacokinetic perspective, and investigate the impact of co-occurring mutations on the efficacy and prognosis of furmonertinib in the treatment of EGFR-mutant NSCLC with leptomeningeal metastasis. The main questions it aims to answer are:
Read full original descriptionShow less
Does the high-dose alternate-day administration regimen have definite efficacy? Does the high-dose alternate-day administration regimen have favorable safety? Does the high-dose alternate-day administration regimen improve efficacy by increasing the cerebrospinal fluid (CSF) concentration and CSF penetration rate of the drug? Which co-occurring mutations may affect the efficacy and prognosis of patients with EGFR-mutant NSCLC and leptomeningeal metastasis? Participants will enter Cohort A (320mg qod po) or Cohort B (160mg qd po) to receive furmonertinib based on their own willingness and the clinician's decision, until disease, progression or uncontrollable adverse reactions occur. All patients in Cohort A will undergo efficacy and safety evaluation, with some also participating in pharmacokinetic study; patients in Cohort B will only undergo pharmacokinetic study.
Efficacy and safety evaluation will be conducted through imaging examinations, neurological function assessment scales, quality of life self-assessment scales, and adverse event records. Pharmacokinetic study will be carried out by detecting the plasma concentrations and CSF concentrations of furmonertinib and its active metabolites, and calculating the CSF penetration rate for evaluation.
The 2 groups in the trial
- Cohort ATreatment being tested
furmonertinib 320mg qod po
Treatment: Furmonertinib 320mg qod po
- Cohort BOther group
furmonertinib 160mg qd po
Treatment: Furmonertinib 160mg qd po
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis
- Plain-language title
- Pulsed high-dose furmonertinib for EGFR lung cancer spread to the brain's liningGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07348965, who can take part
- Record updated
- 2 April 2026