Can a pulsatile drug schedule beat brain metastases in lung cancer?
NCT ID NCT07348965
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial is testing a higher, every-other-day dose of the drug furmonertinib in people with a specific type of lung cancer (EGFR-mutant NSCLC) that has spread to the lining of the brain and spinal cord (leptomeningeal metastasis). The study will compare this high-dose schedule to the standard daily dose to see if it controls the disease better and has acceptable side effects. About 42 participants will choose or be assigned to one of the two dosing schedules and be followed until their disease worsens or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- furmonertinib
- What this could lead to
- If it works, this could offer a more effective way to control NSCLC that has spread to the brain and spinal cord lining, potentially improving survival and quality of life.
- What could go wrong
- This is a small, early-phase study with only 42 participants, so results may not apply broadly. High-dose regimens can also cause more side effects, and the drug may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathological or cytopathological examination 2. Patients with EGFR exon 19 deletion or exon 21 L858R mutation 3. 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) 4. Patients with disease progression after first-line tyrosine kinase inhibitor (TKI) treatment 5. Aged ≥18 years and ≤85 years, with no gender restrictions. 6. 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) 7. For patients enrolled in the pharmacokinetic study: no prior treatment with furmonertinib (either in combination or as monotherapy) 8. 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. Exclusion Criteria: 1. Unable to complete the baseline assessment form 2. Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc. 3. Pregnant or lactating women, or those with planned pregnancy during the study or within 6 months after the study ends 4. Presence of central nervous system complications requiring emergency neurosurgical intervention 5. Suffering from other malignant tumors or having a history of other malignant tumors 6. Complicated with severe brain diseases or mental illnesses that affect the patient's ability to report symptoms by themselves 7. Individuals without legal capacity, or those for whom medical or ethical reasons affect the continuation of the study 8. Other circumstances deemed unsuitable for participation in this study by the researcher. 9. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Guangdong Provincial Hospital of Chinese Medicine
RECRUITINGGuangzhou, Guangdong, 510120, China
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