[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521547":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"China Medical University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nintedanib + gefitinib\u002Ferlotinib\u002Fafatinib\u002Fosimertinib","EXPERIMENTAL","Nintedanib will administered orally twice per day Gefitinib will administered orally once daily Erlotinib will administered orally once daily Afatinib will administered orally once daily Osimertinib will administered orally once daily",[13],"Drug: Nintedanib, gefitinib, erlotinib, afatinib, osimertinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Nintedanib, gefitinib, erlotinib, afatinib, osimertinib","Nintedanib is a multiple tyrosine kinase inhibitor that can bind competitively to the ATP-binding pocket of these receptors and block intracellular signaling, which is critical for the proliferation and migration.\n\nGefitinib, erlotinib and afatinib are the first- and second- generation of EGFR tyrosine kinase inhibitors that reversibly and irreversibly inhibit the binding of ATP to the phosphate-binding loop of ATP binding site in the kinase domain of EGFR, leading to the inhibition of cell proliferation and induction of apoptosis of cancer cells.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Pulmonary Medicine","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Chih-Yen Tu","CONTACT","+886-975-681-007","chesttu@gmail.com",[32],{"facility":5,"status":33,"city":34,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":20},"RECRUITING","Taichung","Taiwan","TW",{"type":38,"coordinates":39},"Point",[40,41],120.6839,24.1469,{"lat":41,"lon":40},{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[46],{"name":47,"class":6},"China Medical University, Taiwan","100521547","phase-1-nintedanib-plus-egfr-tki-in-egfr-mutated-non-small-cell-lung-cancer-patients-100521547",false,"NCT06071013","Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients","A Phase I\u002FPhase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n1. Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.\n2. Positive EGFR mutations are diagenesis.\n3. Participants with histologically\u002Fcytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib.\n4. Participants must have adequate hepatic, renal, and bone marrow function\n\nExclusion Criteria:\n\n1. Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.\n2. Participants have known hypertension, and chronic liver and gastrointestinal disease.\n3. Participants have known brain metastasis.\n4. Female participants who are pregnant or breast-feeding\n5. Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).","ALL","20 Years","70 Years",{"count":59,"type":60},20,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer",[67,68,69],"Non-small Cell Lung Cancer","EGFR Gene Mutation","EGFR-TKI Resistant Mutation",[71,72,73],"nPKC delta","Angiogenesis","EGFR TKI drug resistant","2025-01-20",{"date":76,"type":77},"2025-01-23","ACTUAL",{"date":79,"type":77},"2024-02-23",{"date":81,"type":60},"2026-08-27",{"name":5,"class":6},1]