[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549601":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":11,"responsibleParty":28,"collaborators":11,"id":32,"slug":11,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":53,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":11},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Osimertinib Combined With Etoposide Soft Capsule","EXPERIMENTAL",null,[13],"Drug: Osimertinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Osimertinib","Etoposide Soft Capsules Dosage：25mg\u002Ftablet, 2 tablets\u002Ftime, taken continuously for 21 days, and stopped for one week. Osimertinib Dosage：80mg\u002Ftablet, 1 tablet\u002Ftime, QD, taken for two cycles.",[9],[21],"Etoposide Soft Capsules",[23],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"He Yong","CONTACT","86-23-68757791","heyong8998@126.com",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Yong He","Professor","100549601",false,"NCT06436144","Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC","A Single-Center, Prospective, Single-Arm, Observational Study Evaluating the Efficacy and Safety of Osimertinib Combined With Etoposide as First-Line Treatment in Patients With Osimertinib-Resistant or -Insensitive, Advanced EGFR-Mutant Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age 18 to 79 years.\n2. Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC.\n3. Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R).\n4. Received at least two cycles of first-line osimertinib treatment, with a best response of stable disease or slow progression.\n5. Life expectancy greater than 3 months.\n6. At least one measurable tumor lesion meeting the following criteria:\n\n1.No prior radiation therapy; 2.Measurable by chest CT or PET-CT, with a longest diameter ≥ 10 mm at baseline (short axis ≥ 15 mm for lymph nodes); 3.Amenable to accurate repeated measurements.\n\nExclusion Criteria:\n\n1. Currently receiving or planning to receive other anti-cancer therapies.\n2. Having contraindications to osimertinib or etoposide.\n3. Harboring known targetable osimertinib resistance mechanisms.","ALL","18 Years","80 Years",{"count":42,"type":43},93,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","Osimertinib, though a standard first-line treatment for EGFR-mutant advanced NSCLC, shows primary resistance in 10-30% of patients, leading to disease progression within 3-4 months. This resistance is linked to co-mutations in genes like TP53, RB1, and PIK3CA, among others. Studies indicate that Topo II inhibitor Etoposide (VP-16) can reduce cell survival, enhance DNA damage, and delay resistance in Osimertinib-resistant cells, suggesting a potential combination therapy to manage resistance.This study is a single-center, prospective, single-arm study evaluating the efficacy and safety of osimertinib combined with etoposide as a first-line treatment in patients with osimertinib-resistant or -insensitive advanced non-small cell lung cancer (NSCLC). The study focuses on patients with advanced NSCLC (stage IIIB or IV) with EGFR-sensitive mutations who developed slow resistance to osimertinib and for whom secondary biopsy after resistance did not identify any therapeutic targets.",[49,50,51,52],"Non Small Cell Lung Cancer","EGFR Gene Mutation","Non Small Cell Lung Cancer Stage IIIB","Non-small Cell Lung Cancer Stage IV",[49,50,54],"Primary drug resistance of oxitinib","NOT_YET_RECRUITING","2024-05-28",{"date":58,"type":59},"2024-05-30","ACTUAL",{"date":61,"type":43},"2024-06",{"date":63,"type":43},"2029-12",{"name":5,"class":6}]