[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485242":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":10,"locations":24,"responsibleParty":44,"collaborators":48,"id":145,"slug":10,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":10,"enrollmentInfo":154,"targetDuration":157,"studyType":158,"phases":10,"briefSummary":159,"conditions":160,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy",null,"Stage III-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg\u002FQd or Almonertinib 110mg\u002FQd or Furmonertinib 80mg\u002FQd) as first-line therapy.",[13,14],"Other: Genomic profiles detection","Other: circulating tumor DNA detection",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"Genomic profiles detection","The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing",[9],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"circulating tumor DNA detection","The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing",[9],[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Department of Oncology, The Second Xiangya Hospital, Central South University","RECRUITING","Changsha","Hunan","410011","China",{"type":33,"coordinates":34},"Point",[35,36],112.97087,28.19874,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Fang Wu, MD, PhD","CONTACT","+86 13574858332","wufang4461@csu.edu.cn",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Fang Wu","Associate Professor",[49,51,53,55,57,59,61,63,65,67,69,71,73,75,77,79,82,84,86,88,90,92,94,96,98,100,102,104,107,109,111,113,115,117,119,121,123,125,127,129,131,133,135,137,139,141,143],{"name":50,"class":6},"Xiangya Hospital of Central South University",{"name":52,"class":6},"Shanghai Chest Hospital",{"name":54,"class":6},"West China Hospital",{"name":56,"class":6},"Hunan Cancer Hospital",{"name":58,"class":6},"The Third Xiangya Hospital of Central South University",{"name":60,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":62,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":64,"class":6},"China-Japan Friendship Hospital",{"name":66,"class":6},"Fudan University",{"name":68,"class":6},"First Affiliated Hospital of Kunming Medical University",{"name":70,"class":6},"Loudi Central Hospital",{"name":72,"class":6},"ZhuZhou Central Hospital",{"name":74,"class":6},"Xiangtan Central Hospital",{"name":76,"class":6},"First People's Hospital of Chenzhou",{"name":78,"class":6},"Yueyang Central Hospital",{"name":80,"class":81},"Yongzhou Central Hospital","UNKNOWN",{"name":83,"class":6},"The First Affiliated Hospital of University of South China",{"name":85,"class":6},"Hunan Provincial People's Hospital",{"name":87,"class":81},"Shaoyang Central Hospital",{"name":89,"class":81},"Yiyang Central Hospital",{"name":91,"class":6},"Changsha Central Hospital",{"name":93,"class":6},"The First People's Hospital of Guiyang",{"name":95,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":97,"class":6},"Renmin Hospital of Wuhan University",{"name":99,"class":6},"The First People's Hospital of Changde City",{"name":101,"class":81},"Zhuzhou Second Hospital",{"name":103,"class":81},"First Hospital of Changsha",{"name":105,"class":106},"Hengyang Central Hospital","OTHER_GOV",{"name":108,"class":81},"Huaihua first people's Hospital",{"name":110,"class":81},"The First People's Hospital of Xiangtan",{"name":112,"class":81},"University of South China Affiliated Nanhua Hospital",{"name":114,"class":81},"Xiangxi Autonomous Prefecture People's Hospital",{"name":116,"class":81},"People's Hospital of Zhangjiajie",{"name":118,"class":81},"Second People's Hospital Of Huaihua",{"name":120,"class":81},"Hunan Academy of Traditional Chinese Medicine Affiliated Hospital",{"name":122,"class":81},"The Third Hospital of Changsha",{"name":124,"class":81},"Xiangya Changde Hospital",{"name":126,"class":81},"Changsha County first People's Hospital",{"name":128,"class":81},"Hunan Provincial Straight Hospital of Traditional Chinese Medicine",{"name":130,"class":81},"Liuyang Hospital of traditional Chinese Medicine",{"name":132,"class":6},"Second People's Hospital of Hunan",{"name":134,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":136,"class":81},"Guiyang Public Health Treatment Center",{"name":138,"class":81},"The Affiliated Bethune Hospital of Shanxi Medical University",{"name":140,"class":6},"Hunan University of Traditional Chinese Medicine",{"name":142,"class":6},"Tongji Hospital",{"name":144,"class":6},"The First Affiliated Hospital of Nanchang University","100485242",false,"NCT05598528","Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","PRECISE","Inclusion Criteria:\n\n1. Age \\>18 years;\n2. Histological or cytopathological diagnosed NSCLC;\n3. According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;\n4. At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;\n5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);\n6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;\n7. Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;\n8. Agree to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;\n2. Pregnant and lactating women;\n3. Other malignant neoplastic diseases within 3 years;\n4. Patients who have undergone other clinical drug trials;\n5. Received systemic anti-tumor therapy within 2 years;","ALL","18 Years",{"count":155,"type":156},210,"ESTIMATED","5 Years","OBSERVATIONAL","Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.\n\nHowever, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.\n\nThis study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.",[161,162,163,164,165],"Lung Cancer, Non-small Cell","EGFR Gene Mutation","EGFR-TKI Resistant Mutation","Primary Resistance","Circulating Tumor DNA","2024-11-27",{"date":168,"type":169},"2024-12-02","ACTUAL",{"date":171,"type":169},"2021-09-28",{"date":173,"type":156},"2026-12-31",{"name":5,"class":6},1]