[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557375":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":32,"responsibleParty":49,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hunan Province Tumor Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrathecal Pemetrexed with double Furmonertinib plus bevacizumab","EXPERIMENTAL",null,[13],"Drug: Intrathecal Pemetrexed and high-dose Furmonertinib plus bevacizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Intrathecal Pemetrexed and high-dose Furmonertinib plus bevacizumab","* Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly;\n* Furmonertinib(160mg QD);\n* bevacizumab(5mg\u002Fkg，once monthly) until progressive disease.",[9],[21],"intrathecal pemetrexed, high-dose furmonertinib, bevacizumab",[23,29],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},"Yongchang Zhang, MD","CONTACT","+8613873123436","7+861383123436","zhangyongchang@csu.edu.cn",{"name":30,"role":25,"phone":31,"phoneExt":11,"email":11},"Liang zeng, MD","15974139200",[33],{"facility":34,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hunan Cancer Hospital","Changsha","Hunan","410013","China","CN",{"type":41,"coordinates":42},"Point",[43,44],112.97087,28.19874,{"lat":44,"lon":43},[47],{"name":24,"role":25,"phone":48,"phoneExt":11,"email":28},"+86 731 89762323",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Yongchang Zhang","Head of Medical Oncology, Director of Early Clinical Trial Center","100557375","phase-2-intrathecal-pemetrexed-combined-with-high-dose-furmonertinib-and-beva-for-egfr-m-nsclc-with-leptomeningeal-metastases-100557375",false,"NCT06537297","Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Leptomeningeal Metastases","The Efficacy and Safety of Intrathecal Pemetrexed With High-dose Furmonertinib Plus Bevacizumab for EGFR-mutant NSCLC Patients With Leptomeningeal Metastases Resistant to Third-generation EGFR-TKIs: A Phase II Study.","Inclusion Criteria:\n\n* 1\\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n* 2\\. Age ≥ 18 years.\n* 3\\. Histopathology confirmed Non-small cell lung cancer.\n* 4\\. confirmed or probable leptomeningeal metastases according to EANO-ESMO guidelines or known leptomeningeal metastases progression after third generation of EGFR-TKIs failure.\n* 5.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA (cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent with typical meningeal metastases.\n* 6.ECOG 0 - 2.\n* 7\\. Predicted survival ≥ 12 weeks.\n* 8\\. Adequate bone marrow hematopoiesis and organ function.\n\nExclusion Criteria:\n\n* 1\\. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.\n* 2\\. Subjects who have received any of the following treatments must be excluded: Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n* 3\\. Presence of spinal cord compression.\n* 4\\. History of other malignant tumors within 2 years.\n* 5\\. Adverse events (except alopecia of any degree) of CTCAE \\> grade 4 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n* 6\\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n* 7\\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n* 8\\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n* 9\\. Heart-related diseases or abnormalities\n* 10\\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n* 11\\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb Furmonertinib due to previous bowel resection.\n* 12\\. Live vaccine was given 2 weeks before the first medication.\n* 13\\. Women who are breastfeeding or pregnant.\n* 14\\. Hypersensitivity to the test drug and the ingredients.\n* 15\\. Other conditions assessed by the investigator to be unsuitable for participation in the study.","ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs.",[70],"Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2024-09-17",{"date":74,"type":75},"2024-09-20","ACTUAL",{"date":77,"type":64},"2024-09-30",{"date":79,"type":64},"2026-04-30",{"name":5,"class":6},1]