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New treatment option for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis
ClinicalTrials.gov ID: NCT07348965
What this study is testing
What is Furmonertinib 320mg qod po?
Furmonertinib 320mg qod po is an investigational medicine, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Patients with disease progression after first-line tyrosine kinase inhibitor (TKI) treatment
- Aged ≥18 years and ≤85 years, with no gender restrictions.
You likely can't join if
- Unable to complete the baseline assessment form
- Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc.
- 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
- 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
See the full eligibility criteria
- 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...
- 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...
- 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.
- Unable to complete the baseline assessment form
- Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc.
- 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
- 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
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.