[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575000":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":27,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":56,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":11},{"fullName":5,"class":6},"Jiangsu Province Nanjing Brain Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ivonescimab combined with chemotherapy","EXPERIMENTAL",null,[13],"Drug: Ivonescimab combined with chemotherapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Ivonescimab combined with chemotherapy. The specific chemotherapy regimen is based on the real world.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Cun shen Fang, Dr","CONTACT","13404163638","fang1984@aliyun.com",{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[28,31],{"name":29,"class":30},"Henan Cancer Hospital","OTHER_GOV",{"name":32,"class":6},"Three Gorges Hospital of Chongqing University","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":44,"type":45},36,"ESTIMATED","INTERVENTIONAL",[48],"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",[51,52,53,54,55],"NSCLC","Chemotherapy","Leptomeningeal Metastases","EGFR-TKI","AK112",[57,51,58,54,59,60],"Ivonescimab","leptomeningeal metastases","VEGF","PD-1\u002FVEGF bispecific antibody","NOT_YET_RECRUITING","2025-01-05",{"date":64,"type":65},"2025-01-09","ACTUAL",{"date":67,"type":45},"2025-01-01",{"date":69,"type":45},"2025-10-31",{"name":5,"class":6}]