[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"furmonertinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:furmonertinib":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100619772","pulsatile-high-dose-furmonertinib-in-egfr-mutant-nsclc-with-leptomeningeal-metastasis-100619772",false,"NCT07348965","Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis","Inclusion Criteria:\n\n1. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathological or cytopathological examination\n2. Patients with EGFR exon 19 deletion or exon 21 L858R mutation\n3. 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)\n4. Patients with disease progression after first-line tyrosine kinase inhibitor (TKI) treatment\n5. Aged ≥18 years and ≤85 years, with no gender restrictions.\n6. Sufficient organ function, defined as: absolute neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 75×10⁹\u002FL, hemoglobin ≥ 90g\u002FL 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\u002FAST can be relaxed to ≤ 5×ULN) serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n7. For patients enrolled in the pharmacokinetic study: no prior treatment with furmonertinib (either in combination or as monotherapy)\n8. 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.\n\nExclusion Criteria:\n\n1. Unable to complete the baseline assessment form\n2. Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc.\n3. Pregnant or lactating women, or those with planned pregnancy during the study or within 6 months after the study ends\n4. Presence of central nervous system complications requiring emergency neurosurgical intervention\n5. Suffering from other malignant tumors or having a history of other malignant tumors\n6. Complicated with severe brain diseases or mental illnesses that affect the patient's ability to report symptoms by themselves\n7. Individuals without legal capacity, or those for whom medical or ethical reasons affect the continuation of the study\n8. Other circumstances deemed unsuitable for participation in this study by the researcher.\n9. 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).","ALL","18 Years","75 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"NA","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:\n\nDoes 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.\n\nEfficacy 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.",[26,27,28,29],"NSCLC (Advanced Non-small Cell Lung Cancer)","Leptomeningeal Metastasis","Furmonertinib","EGFR Activating Mutation",[31,32,33,34],"NSCLC","furmonertinib","leptomeningeal metastasis","cerebrospinal fluid","RECRUITING","2026-03-31",{"date":38,"type":39},"2026-04-02","ACTUAL",{"date":41,"type":39},"2026-03-01",{"date":43,"type":20},"2028-12-31",{"name":45,"class":46},"Guangzhou University of Traditional Chinese Medicine","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100621037","phase-2-furmonertinib-160mg-vs-80mg--chemotherapy-in-egfr-mutated-nsclc-with-brain-metastases-efficacy-and-safety-study-100621037","NCT07365410","Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study","Furmonertinib 160mg Versus Furmonertinib 80mg Combined With Chemotherapy (Carboplatin + Pemetrexed) as First-Line Treatment for EGFR-Mutated NSCLC Patients With Brain Metastases: A Multicenter Study of Efficacy and Safety","IInclusion Criteria\n\n* Aged 18 to 75 years (male or female)\n* Histopathologically confirmed, unresectable, and non-radiocurable newly -diagnosed locally advanced or metastatic lung adenocarcinoma\n* Confirmed by local laboratory to have one of the following EGFR mutations: -19Del or L858R (single or mixed mutations are allowed)\n* Treatment-naive for locally advanced (not suitable for surgery\u002Fradiotherapy per investigator) or metastatic NSCLC; adjuvant\u002Fneoadjuvant therapy completed \\>6 months before first progression is allowed (≤6 months is considered pretreated)\n* At least one measurable tumor lesion per RECIST 1.1 (lesions previously treated with radiotherapy are excluded; if only one measurable lesion exists, biopsy is allowed but baseline imaging must be performed ≥14 days after biopsy)\n* Confirmed stable and asymptomatic brain metastases\n* Sufficient organ function (per laboratory tests): ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, HGB ≥90g\u002FL; TBIL ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (for liver metastasis: TBIL ≤3×ULN, AST\u002FALT ≤5×ULN); CrCL ≥50 ml\u002Fmin (Cockcroft-Gault formula)\n* ECOG performance status 0-2 (no significant disease deterioration in 2 weeks before screening)\n* Expected survival \\>12 weeks after first dose\n* Non-pregnant women of childbearing potential (no pregnancy plan); women and men agree to use effective contraception during the study and 6 months after drug discontinuation\n* Voluntarily signs informed consent and understands the study procedures Exclusion Criteria（排除标准）\n* NSCLC with predominantly squamous cell histology, small cell lung cancer, neuroendocrine carcinoma, or other non-adenocarcinoma histologies\n* Concurrent positive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation); TP53, RB1, and BRAC mutations are excluded\n* Expected to receive other anti-tumor therapies during the trial\n* Major surgery (except vascular access or biopsy) within 4 weeks before first dose or planned during the trial\n* Use of CYP3A4 strong inhibitor within 7 days or strong inducer within 21 days before first dose; use of anti-tumor Chinese medicine within 2 weeks before first dose or planned during the trial\n* Participation in other clinical trials (investigational drug\u002Fdevice) within 4 weeks or 5 half-lives before first dose\n* Use of other anti-tumor drugs within 14 days before first dose\n* Spinal cord compression or symptomatic leptomeningeal metastasis\n* Toxicity from previous anti-tumor therapy not recovered to ≤CTCAE Grade 1 (except alopecia or platinum-induced peripheral neuropathy)\n* Symptomatic or unstable pleural\u002Fperitoneal effusion (stable ≥14 days after drainage is allowed)\n* History of other malignancies (except cured malignancies with no recurrence in 5 years: cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma)\n* History of interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or suspected ILD\n* Uncontrolled severe systemic diseases (e.g., hypertension, diabetes, NYHA III-IV heart failure, unstable angina, myocardial infarction within 1 year, active bleeding)\n* QTc \\>470 msec on resting ECG\n* Clinically significant QT prolongation or arrhythmias increasing QT risk (e.g., complete left bundle branch block, III° AV block, congenital long QT syndrome, severe hypokalemia, use of drugs causing QT prolongation)\n* Severe gastrointestinal dysfunction that impairs drug intake or absorption Infections requiring intravenous medication\n* Active mental illness or drug addiction\n* Known or suspected allergy to furmonertinib or its components\n* Pregnant or lactating women; women or their partners planning pregnancy during the study\n* Poor compliance (unable to follow study procedures)\n* Other conditions deemed unsuitable for enrollment by the investigator",{"count":56,"type":20},60,[58],"PHASE2","This multicenter study evaluates the efficacy and safety of furmonertinib 160mg versus furmonertinib 80mg plus chemotherapy (carboplatin + pemetrexed) as first-line treatment for EGFR-mutated NSCLC patients with brain metastases. It aims to determine which approach is more effective and safer.",[61,62,28,63],"Non-small Cell Lung Cancer (NSCLC)","Brain Metastases","EGFR Mutation","NOT_YET_RECRUITING","2026-01-23",{"date":67,"type":39},"2026-01-26",{"date":69,"type":20},"2026-01",{"date":71,"type":20},"2028-12",{"name":73,"class":46},"Tianjin Medical University Cancer Institute and Hospital"]