[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485242":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":10,"locations":24,"responsibleParty":45,"collaborators":49,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":10,"enrollmentInfo":156,"targetDuration":159,"studyType":160,"phases":10,"briefSummary":161,"conditions":162,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"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,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Department of Oncology, The Second Xiangya Hospital, Central South University","RECRUITING","Changsha","Hunan","410011","China","CN",{"type":34,"coordinates":35},"Point",[36,37],112.97087,28.19874,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Fang Wu, MD, PhD","CONTACT","+86 13574858332","wufang4461@csu.edu.cn",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Fang Wu","Associate Professor",[50,52,54,56,58,60,62,64,66,68,70,72,74,76,78,80,83,85,87,89,91,93,95,97,99,101,103,105,108,110,112,114,116,118,120,122,124,126,128,130,132,134,136,138,140,142,144],{"name":51,"class":6},"Xiangya Hospital of Central South University",{"name":53,"class":6},"Shanghai Chest Hospital",{"name":55,"class":6},"West China Hospital",{"name":57,"class":6},"Hunan Cancer Hospital",{"name":59,"class":6},"The Third Xiangya Hospital of Central South University",{"name":61,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":63,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":65,"class":6},"China-Japan Friendship Hospital",{"name":67,"class":6},"Fudan University",{"name":69,"class":6},"First Affiliated Hospital of Kunming Medical University",{"name":71,"class":6},"Loudi Central Hospital",{"name":73,"class":6},"ZhuZhou Central Hospital",{"name":75,"class":6},"Xiangtan Central Hospital",{"name":77,"class":6},"First People's Hospital of Chenzhou",{"name":79,"class":6},"Yueyang Central Hospital",{"name":81,"class":82},"Yongzhou Central Hospital","UNKNOWN",{"name":84,"class":6},"The First Affiliated Hospital of University of South China",{"name":86,"class":6},"Hunan Provincial People's Hospital",{"name":88,"class":82},"Shaoyang Central Hospital",{"name":90,"class":82},"Yiyang Central Hospital",{"name":92,"class":6},"Changsha Central Hospital",{"name":94,"class":6},"The First People's Hospital of Guiyang",{"name":96,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":98,"class":6},"Renmin Hospital of Wuhan University",{"name":100,"class":6},"The First People's Hospital of Changde City",{"name":102,"class":82},"Zhuzhou Second Hospital",{"name":104,"class":82},"First Hospital of Changsha",{"name":106,"class":107},"Hengyang Central Hospital","OTHER_GOV",{"name":109,"class":82},"Huaihua first people's Hospital",{"name":111,"class":82},"The First People's Hospital of Xiangtan",{"name":113,"class":82},"University of South China Affiliated Nanhua Hospital",{"name":115,"class":82},"Xiangxi Autonomous Prefecture People's Hospital",{"name":117,"class":82},"People's Hospital of Zhangjiajie",{"name":119,"class":82},"Second People's Hospital Of Huaihua",{"name":121,"class":82},"Hunan Academy of Traditional Chinese Medicine Affiliated Hospital",{"name":123,"class":82},"The Third Hospital of Changsha",{"name":125,"class":82},"Xiangya Changde Hospital",{"name":127,"class":82},"Changsha County first People's Hospital",{"name":129,"class":82},"Hunan Provincial Straight Hospital of Traditional Chinese Medicine",{"name":131,"class":82},"Liuyang Hospital of traditional Chinese Medicine",{"name":133,"class":6},"Second People's Hospital of Hunan",{"name":135,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":137,"class":82},"Guiyang Public Health Treatment Center",{"name":139,"class":82},"The Affiliated Bethune Hospital of Shanxi Medical University",{"name":141,"class":6},"Hunan University of Traditional Chinese Medicine",{"name":143,"class":6},"Tongji Hospital",{"name":145,"class":6},"The First Affiliated Hospital of Nanchang University","100485242","exploring-the-mechanism-of-primary-resistance-to-third-generation-egfr-tkis-as-first-line-treatment-in-egfr-positive-advanced-nsclc-precise-study-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":157,"type":158},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.",[163,164,165,166,167],"Lung Cancer, Non-small Cell","EGFR Gene Mutation","EGFR-TKI Resistant Mutation","Primary Resistance","Circulating Tumor DNA","2024-11-27",{"date":170,"type":171},"2024-12-02","ACTUAL",{"date":173,"type":171},"2021-09-28",{"date":175,"type":158},"2026-12-31",{"name":5,"class":6},1]