[{"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":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"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":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28,29,30],"NSCLC","Chemotherapy","Leptomeningeal Metastases","EGFR-TKI","AK112",[32,26,33,29,34,35],"Ivonescimab","leptomeningeal metastases","VEGF","PD-1\u002FVEGF bispecific antibody","NOT_YET_RECRUITING","2025-01-05",{"date":39,"type":40},"2025-01-09","ACTUAL",{"date":42,"type":20},"2025-01-01",{"date":44,"type":20},"2025-10-31",{"name":46,"class":47},"Jiangsu Province Nanjing Brain Hospital","OTHER",{"id":49,"slug":4,"hasResults":10,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"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":55,"type":20},40,[57],"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.",[60,29,61],"Paronychia","ALK-TKI",[63,64,65,61],"EGFR TKI","paronychia","timolol","RECRUITING","2024-10-16",{"date":69,"type":40},"2024-10-18",{"date":71,"type":20},"2024-10-09",{"date":73,"type":20},"2025-12-31",{"name":75,"class":47},"Queen Mary Hospital, Hong Kong",1,""]