[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657278":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":16,"studyPopulation":35,"armGroups":36,"interventions":46,"overallOfficials":16,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":16,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":16,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":93,"studyType":94,"phases":16,"briefSummary":95,"conditions":96,"keywords":16,"overallStatus":61,"whyStopped":16,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Tongji Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-Free Survival (DFS)","Time from the date of surgery to investigator-confirmed disease recurrence or death from any cause, whichever occurs first.","From surgery until disease recurrence or death, assessed up to 3 years",[14,18,21,24,26,29],{"measure":15,"description":16,"timeFrame":17},"2-Year Disease-Free Survival Rate",null,"2 years after surgery.",{"measure":19,"description":16,"timeFrame":20},"Overall Survival (OS)","From date of enrollment until the date of death from any cause, assessed up to 60 months",{"measure":22,"description":16,"timeFrame":23},"5-Year Disease-Free Survival Rate","5 years after surgery",{"measure":25,"description":16,"timeFrame":23},"5-Year Overall Survival Rate",{"measure":27,"description":16,"timeFrame":28},"Incidence and Severity of Adverse Events","Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, and every 12 weeks thereafter until date of death from any cause, assessed up to 60 months",{"measure":30,"description":16,"timeFrame":31},"Change in SF-36 Health-Related Quality of Life Scores","Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, every 12 weeks during the first 3 years, and every 6 months thereafter until date of death from any cause, assessed up to 60 months",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":33,"timePerspective":34,"maskingInfo":16},"COHORT","PROSPECTIVE","Adults with EGFR-mutant, completely resected high-risk stage IA2 to stage IIB NSCLC\u002Flung adenocarcinoma who are treated and followed at participating thoracic oncology centers in Hubei Province, China.",[37,42],{"label":38,"type":16,"description":39,"interventionNames":40},"Common Sensitizing EGFR Mutation Cohort","Participants with common sensitizing EGFR mutations, including exon 19 deletion and L858R, following complete surgical resection of high-risk stage IA2-IIB NSCLC.",[41],"Drug: Adjuvant EGFR-TKI Therapy",{"label":43,"type":16,"description":44,"interventionNames":45},"Uncommon\u002FResistant EGFR Mutation Cohort","Participants with uncommon or resistant EGFR mutations, including exon 20 insertion and PACC mutations, following complete surgical resection of high-risk stage IA2-IIB NSCLC.",[41],[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":16},"DRUG","Adjuvant EGFR-TKI Therapy","Routine-care postoperative EGFR-TKI therapy. First-generation options include gefitinib, erlotinib, and icotinib; third-generation options include furmonertinib, osimertinib, and almonertinib. Maximum planned duration is 3 years.",[38,43],[53],{"name":54,"role":55,"phone":56,"phoneExt":16,"email":57},"Wei Ping, Dr.","CONTACT","13437101581","pingwei@tjh.tjmu.edu.cn",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":68,"coordinates":69},"Point",[70,71],114.26667,30.58333,{"lat":71,"lon":70},[74],{"name":75,"role":55,"phone":56,"phoneExt":16,"email":57},"Wei Ping",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Zhang Ni","Professor","100657278","adjuvant-egfr-tki-therapy-after-surgery-for-egfr-mutant-high-risk-stage-ia2-iib-nsclc-100657278",false,"NCT07837739","Adjuvant EGFR-TKI Therapy After Surgery for EGFR-Mutant High-Risk Stage IA2-IIB NSCLC","A Multicenter Registry Study of Adjuvant EGFR-TKI Therapy Following Curative Resection for EGFR-Mutant High-Risk Stage IA2-IIB Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18-75 years, male or female, with written informed consent.\n* Histologically confirmed primary non-small cell lung cancer, pathologic stage IA2 to IIB; protocol summary further specifies lung adenocarcinoma \u002F predominantly non-squamous histology.\n* For stage IA2 disease, at least one protocol-defined high-risk feature: invasive component \\>2 cm; lymphovascular invasion; high-grade pattern comprising ≥20% solid, micropapillary, cribriform, or complex glandular components; spread through air spaces (STAS); or sublobar resection (segmentectomy\u002Fwedge resection).\n* EGFR mutation-positive disease confirmed by the central laboratory, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutation.\n* Complete surgical resection with negative margins (R0); lobectomy or sublobar resection may be included according to the protocol.\n* No previous antitumor treatment, including no neoadjuvant radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n* ECOG Performance Status 0-1.\n* Hematologic criteria: RBC ≥3.0×10\\^12\u002FL; WBC ≥3.5×10\\^9\u002FL; ANC ≥1.5×10\\^9\u002FL; platelet count ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n* Renal function: serum creatinine ≤1.2×ULN.\n* Hepatic function: total bilirubin ≤1.5×ULN; ALT and AST ≤1.5×ULN.\n* Able and willing to comply with protocol-specified treatment\u002Fobservation and follow-up.\n* Adequate tumor tissue available and willingness to provide tissue and blood samples for study analyses.\n* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.\n\nExclusion Criteria:\n\n* Contraindication to anesthesia or surgery, or death attributable to the surgical procedure before study enrollment\u002Fevaluation.\n* Any systemic disease incompatible with participation in the clinical study or inability to provide written informed consent.\n* Pregnancy or breastfeeding.\n* Known active alcohol or drug abuse or dependence.\n* Any serious or unstable medical condition or psychiatric disorder that, in the investigator's judgment, would make participation inappropriate.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","ALL","18 Years","75 Years",{"count":91,"type":92},100,"ESTIMATED","3 Years","OBSERVATIONAL","This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection.\n\nPostoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient\u002Fphysician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon\u002Fresistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.",[97],"Non-Small Cell Lung Cancer","2026-09-17",{"date":100,"type":101},"2026-09-23","ACTUAL",{"date":103,"type":101},"2025-07-02",{"date":105,"type":92},"2026-12-31",{"name":5,"class":6},1]