[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564860":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":48,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":19,"overallStatus":68,"whyStopped":19,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hunan Province Tumor Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"The experimental cohort","EXPERIMENTAL","third-generation EGFR-TKI combined with anlotinib",[13],"Drug: third-generation EGFR-TKI combined with anlotinib",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yongchang Zhang","CONTACT","+8613873123436","zhangyongchang@csu.edu.cn",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Liang Zeng","15974139200","530490930@qq.com",[31],{"facility":22,"status":19,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Changsha","Hunan","410013","China","CN",{"type":38,"coordinates":39},"Point",[40,41],112.97087,28.19874,{"lat":41,"lon":40},[44,46],{"name":45,"role":23,"phone":24,"phoneExt":24,"email":25},"Yongchang Zhang, MD",{"name":45,"role":47,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":22,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Director, Head of Medical Oncology, Principal Investigator, Clinical Professor","100564860","phase-2-third-generation-egfr-tki-plus-anlotinib-as-maintenance-for-nsclc-with-small-cell-transformation-after-egfr-tki-resistance-100564860",false,"NCT06634667","Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance","Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective 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 is confirmed non-small cell lung cancer .\n* 4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.\n* 5\\. Predicted survival ≥ 12 weeks. .\n* 6\\. ECOG 0-2.\n* 7\\. Adequate bone marrow hematopoiesis and organ function.\n\nExclusion Criteria:\n\n* 1\\. History of other malignant tumors within 2 years.\n* 2\\. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n* 3\\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n* 4\\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n* 5\\. 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* 6\\. Heart-related diseases or abnormalities\n* 7\\. 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* 8\\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.\n* 9\\. Live vaccine was given 2 weeks before the first medication.\n* 10\\. Women who are breastfeeding or pregnant.\n* 11\\. Hypersensitivity to the test drug and the ingredients.\n* 12\\. Other conditions assessed by the investigator to be unsuitable for participation in the study.","ALL","18 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.",[67],"Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2024-10-08",{"date":71,"type":72},"2024-10-10","ACTUAL",{"date":74,"type":61},"2024-11-30",{"date":76,"type":61},"2027-04-30",{"name":5,"class":6},1]