[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-tki\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-tki":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100575000","ivonescimab-combined-with-chemotherapy-for-the-treatment-of-leptomeningeal-metastases-failed-to-egfr-tkis-100575000",false,"NCT06766591","Ivonescimab Combined With Chemotherapy for the Treatment of Leptomeningeal Metastases Failed to EGFR-TKIs","Ivonescimab Combined With Chemotherapy for EGFR Mutant NSCLC With Leptomeningeal Metastasis After EGFR TKIs Resistance: A Multicenter Observational Study.","Inclusion Criteria:\n\n* Age range: 18-75y\n* EGFR mutation NSCLC\n* LM was diagnosed through head enhanced MRI or (and) CSF cytology\n* EGFR activation mutations were positive\n* Patients who have failed to first or second-generation EGFR-TKI treatment，without T790M mutation; or failed to third-generation EGFR-TKI treatment\n* Hematological, coagulation, renal and liver function is sufficient\n* Women of childbearing age must undergo a pregnancy test and the result must be negative\n\nExclusion Criteria:\n\n* Patients with squamous cell carcinoma, large cell carcinoma, mixed cell lung cancer\n* The patient has other driver genes that can be treated with targeted drugs\n* Subjects who have previously received immunotherapy with a discontinuation time of less than 3 months\n* Received EGFR-TKI treatment within one week prior to the first administration\n* Received non-specific immunomodulatory therapy\n* Clinical manifestations of neurological failure\n* Non malignant neurological disorders\n* Radiotherapy for the chest and whole brain should be completed within 4 weeks before enrollment\n* Tumor surrounded important blood vessels or had obvious necrosis or cavities\n* Tumor has invaded important surrounding organs and blood vessels\n* History of severe bleeding tendency or coagulation dysfunction\n* The risk of developing esophagotracheal fistula or esophageal pleural fistula","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","Research objective Main purpose Exploring the real-world effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis after EGFR-TKIs resistance. Outcome measure: Real world intracranial disease-free survival time (iPFS).\n\nSecondary purpose Federation patterns: describing different treatment modes in the real world; Outcome measures: Combination chemotherapy regimen and duration of chemotherapy.\n\nEfficacy: Further explore the effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis failed with EGFR-TKI treatment; Outcome measures: Objective response rate (LM-ORR), duration of intracranial response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, CSF response rate based on CSF cytology.\n\nSafety: Explore the safety of Ivonescimab combined with chemotherapy for NSCLC patients with leptomeningeal metastases who have failed EGFR-TKI treatment; Outcome measures: incidence of adverse events (TEAEs), laboratory test outliers, and serious adverse events (SAEs).\n\nResearch endpoint Primary endpoint\n\n* iPFS (intracranial progression free survival). Secondary endpoint\n* Efficacy: leptomeningeal ORR (LM-ORR), intracranial duration of response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, and CSF response rate based on CSF cytology;\n* Safety: Determine the incidence and severity of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE5.0 standards; Changes in vital signs, laboratory abnormalities, and quality of life scores.\n\nExploratory endpoint: efficacy related biomarkers",[27,28,29,30,31],"NSCLC","Chemotherapy","Leptomeningeal Metastases","EGFR-TKI","AK112",[33,27,34,30,35,36],"Ivonescimab","leptomeningeal metastases","VEGF","PD-1\u002FVEGF bispecific antibody","NOT_YET_RECRUITING","2025-01-05",{"date":40,"type":41},"2025-01-09","ACTUAL",{"date":43,"type":21},"2025-01-01",{"date":45,"type":21},"2025-10-31",{"name":47,"class":48},"Jiangsu Province Nanjing Brain Hospital","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100565533","phase-3-efficacy-and-safety-of-add-on-timolol-for-egfr-tki-and-alk-tki-induced-paronychia-100565533","NCT06643416","Efficacy and Safety of Add-on Timolol for EGFR-TKI and ALK-TKI Induced Paronychia","Efficacy and Safety of Add-on Topical Timolol in the Management of Epidermal Growth Factor and Anaplastic Lymphoma Kinase Receptor Tyrosine Kinase Inhibitor-induced Paronychia: a Prospective Randomized Open-labelled Trial","Inclusion criteria\n\n1. Aged 18 years or above, either males or females.\n2. Received EGFR-TKI and ALK-TKI, namely gefitinib, erlotinib, afatinib, osimertinib, amivantamab, dacomitinib, mobocertinib, crizotinib, ceritinib, alectinib, brigatinib and lorlatinib for the treatment of non-small cell lung cancer.\n3. Paronychia (fingernails, toenails, or both) as an adverse event from EGFR-TKI use\n4. Written informed consent obtained from patient\n5. Subjects are diagnosed with advanced non-small cell lung cancer\n\nExclusion criteria\n\n1. 1\\. Age below18\n2. 2\\. Patients who are allergic to, or contraindicated to topical timolol use\n3. 3\\. Pregnant women or nursing mother\n4. 4\\. Non-consenting patients\n5. 5\\. Subjects are not diagnosed with advanced non-small cell lung cancer",{"count":57,"type":21},40,[59],"PHASE3","To assess the clinical efficacy of add-on topical timolol 0.5% eye drops to betamethasone valerate 0.1% for the treatment of EGFR-TKI and ALK-TKI induced paronychia.",[62,30,63],"Paronychia","ALK-TKI",[65,66,67,63],"EGFR TKI","paronychia","timolol","RECRUITING","2024-10-16",{"date":71,"type":41},"2024-10-18",{"date":73,"type":21},"2024-10-09",{"date":75,"type":21},"2025-12-31",{"name":77,"class":48},"Queen Mary Hospital, Hong Kong",1]