New combo therapy targets hard-to-treat brain metastasis in lung cancer patients
NCT ID NCT07398599
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a higher dose of a targeted therapy (EGFR-TKI) combined with two other drugs for people with advanced lung cancer that has spread to the lining of the brain and worsened on standard treatment. About 30 participants will receive the triple combination to see if it shrinks the brain lining tumors and to track side effects. The goal is to control the disease, not cure it, as ongoing treatment is needed.
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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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2027
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 99 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 * Aged ≥ 18 years at the time of signing the informed consent form, regardless of gender. * Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), staged as IV according to the 8th edition of the IASLC TNM classification (2015). * Presence of EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation). * Leptomeningeal metastasis (LM) progression after standard-dose first-, second-, or third-generation EGFR-TKI treatment. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate major organ function, defined as: hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count (PLT) ≥ 100 × 10\^9/L, white blood cell count (WBC) ≥ 3.0 × 10\^9/L and ≤ 10.0 × 10\^9/L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 50 ml/min (for patients with liver metastases, TBIL ≤ 3.0 × ULN, ALT and AST ≤ 5.0 × ULN); activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤ 1.5 × ULN. * At least 21 days since the last radiotherapy (including whole-brain radiotherapy or local radiotherapy for brain metastases). * Expected survival ≥ 3 months. * Ability to swallow oral medications (or receive crushed medications via gastrostomy tube if unable to swallow). * For women: Agreement to use effective contraception (e.g., surgical sterilization or protocol contraception) within 14 days prior to enrollment, during the study, and for 3 months after the last study drug administration. * For men: Agreement to use effective contraception (e.g., surgical sterilization or protocol contraception) during the study and for 3 months after the last study drug administration. * Voluntary participation, signed informed consent, and willingness to comply with study procedures and protocols. Exclusion Criteria * Major surgery within 4 weeks prior to the start of study treatment, or need for major surgery during the study. * Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). * Active bacterial/fungal/viral infections requiring intravenous antibiotic therapy. * Drug-induced pneumonitis or interstitial lung disease, or evidence of clinically significant active pulmonary disease. * Severe cardiovascular events within 6 months prior to enrollment, including cerebrovascular accident, deep vein thrombosis, or pulmonary embolism. * Significant cardiovascular disease, such as New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, symptomatic arrhythmias requiring treatment, or corrected QT interval (QTcF) \> 470 ms on consecutive electrocardiograms. * History of other systemic malignant tumors within the past 5 years (except for cured basal cell carcinoma, carcinoma in situ of the cervix, and ovarian cancer). * Use of drugs or supplements known to be strong inducers of CYP3A4. * Known severe allergy to any study drug or its excipients. * Pregnancy, lactation, or refusal of effective contraception by patients of childbearing potential. * History of definite neurological or psychiatric disorders (including epilepsy and dementia). * Other conditions deemed unsuitable for enrollment by the investigator.
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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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The Second Affiliated Hospital of Nanchang University
RECRUITINGNanchang, Jiangxi, China
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Other studies related to the condition(s) this trial covers.
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