[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549975":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Fujian Cancer Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed","EXPERIMENTAL",null,[13,14],"Drug: Double Dose of Third-generation EGFR-TKI","Drug: Intrathecal Pemetrexed",{"label":16,"type":17,"description":11,"interventionNames":18},"Double Dose of Third-generation EGFR-TKI","ACTIVE_COMPARATOR",[13],[20,23],{"type":21,"name":16,"description":16,"armGroupLabels":22,"otherNames":11},"DRUG",[16,9],{"type":21,"name":24,"description":24,"armGroupLabels":25,"otherNames":11},"Intrathecal Pemetrexed",[9],[27],{"name":28,"affiliation":29,"role":30},"Gen Lin","Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":11,"email":35},"CONTACT","13313786157","lingen197505@163.com",[37],{"facility":28,"status":11,"city":38,"state":39,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fuzhou","Fujian","China","CN",{"type":43,"coordinates":44},"Point",[45,46],119.30611,26.06139,{"lat":46,"lon":45},[49],{"name":28,"role":33,"phone":11,"phoneExt":11,"email":35},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100549975","phase-2-double-dose-of-third-generation-egfr-tki-plus-intrathecal-pemetrexed-versus-double-dose-of-third-generation-egfr-tki-in-patients-with-lm-progression-following-the-treatment-of-routine-dose-of-third-generation-egfr-tki-100549975",false,"NCT06441045","Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in Patients With LM Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI","Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in NSCLC Patients With Leptomeningeal Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI: a Phase II Randomized, Multicenter Study","Inclusion Criteria:\n\n* Age 18 years at the time of signing informed consent, both sexes;\n* advanced or metastatic NSCLC, TNM stage IV according to the eighth edition of IASLC 2015;\n* with EGFR sensitive mutation (exon 19 deletion or L858R mutation), LM progression after conventional doses of three generation EGFR targeted agents (after 1 + 3,2 + 3 or direct 3-generation targeted therapy). There is no limit on the number of chemotherapy lines. The enrolled patients required brain parenchyma and extracranial lesion stable\n* ECOG PS score: 0-3\n* Normal main organ function, That is, the following criteria are met:\n\n  1. routine blood examination (no blood transfusion within 14 days, no hematopoietic stimulating factor drugs are corrected state): hemoglobin (Hb) 90g \u002F L; Absolute neutrophil count (ANC) 1.5109 \u002F L; Platelet (PLT) 100109 \u002F L; White blood cell count (WBC) 3.0109 \u002F L;\n  2. Biochemical examination: alanine transaminotransferase (ALT) and alanine transaminotransferase (AST) 2.5 upper limit of normal (ULN); Serum total bilirubin (TBIL) 1.5 ULN; Serum creatinine (Cr) of 1.5 ULN or creatinine clearance of 50 ml\u002Fmin; If any liver metastasis, Then, the total bilirubin 3 ULN, ALT and AST 5 ULN; C) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time 12 (PT) 1.5 ULN;\n\n  d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) 50%;\n* If previously treated with chemotherapy, A washout period of at least 21 days between the last chemotherapy dose and enrollment (if the patient does not receive radiotherapy) is required; Patients who treated brain parenchymal metastases with local radiotherapy or surgery before enrollment, Must be completed and fully recovered from the acute toxicity of radiotherapy \u002F surgery. A minimum 14-day washout period is required between the end of radiotherapy and enrollment. A minimum 30-day washout period is required between the end of surgery and enrollment.\n* Expected survival of not less than 3 months\n* patients can swallow oral medication (if not oral, can be ground by gastric tube)\n* Women of childbearing age must have negative pregnancy test (serum or urine) within 14 days before observation period and 3 months after the last administration; for men, they should undergo surgical sterilization or agree to use appropriate contraception during the observation period and 3 months after the last administration of study drug\n* patients voluntarily participate and sign an informed consent (or legal agent), expected to have good compliance and able to cooperate with the study according to the protocol requirements.\n\nExclusion Criteria:\n\n* Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the study program;\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)\n* patient with active bacterial infection, fungal infection (intravenous antibiotics required at initiation of study treatment);\n* past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid therapy, Or any signs of clinically active interstitial lung disease;\n* arterial \u002F venous thrombosis events within 6 months prior to enrollment, Such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n* congestive heart failure (NYHA grade\\> 2); unstable angina pectoris; a myocardial infarction within 3 months prior to signing an ICF; any 12 supraventricular or ventricular arrhythmia requiring treatment or intervention; Mean QTcF\\> 470ms from 3 ECG recordings\n* other systemic malignancies in the last 5 years, (Except for cured skin basal cell carcinoma and cervical situ carcinoma and ovarian carcinoma);\n* Use drugs or supplements known to be the main cause of CYP3A4.\n* Persons known to be allergic to any test drug or its excipients;\n* pregnant, lactating, reproductive patients unwilling to use effective contraception; ●a clear prior history of neurological or psychiatric disorders, including epilepsy and dementia;\n* other conditions considered inappropriate by the investigator.","ALL","18 Years",{"count":62,"type":63},112,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","We aim to compare the efficacy and safety of double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus double Dose of Third-generation EGFR-TKI in patients with leptomeningeal progression following the treatment of routine dose of EGFR-TKI,",[69],"Leptomeningeal Metastasis","NOT_YET_RECRUITING","2024-06-03",{"date":73,"type":74},"2024-06-04","ACTUAL",{"date":76,"type":63},"2024-10-01",{"date":78,"type":63},"2028-10-01",{"name":5,"class":6},1]