[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475292":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":37,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":31,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":31,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Konkuk University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Lazertinib","EXPERIMENTAL","Lazertinib as neoadjuvant treatment is administrated for 9 weeks before surgery. After surgical intervention the treatment is administrated upto 3 years to the patients with over stage 2 tumor. Treatment is discontinued in case of unacceptable toxicity or disease progression.",[13],"Drug: Neoadjuvant lazertinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Neoadjuvant lazertinib","Lazertinib 240mg p.o once daily.",[9],[21],"Neoadjuvant LECLAZA",[23],{"name":24,"affiliation":5,"role":25},"Kye Young Lee","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"In Ae Kim, MD. PhD.","CONTACT","+821035438353",null,"20180618@kuh.ac.kr",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Kye Young Lee, MD,PhD.","821088963916","kyleemd@kuh.ac.kr",[38],{"facility":5,"status":39,"city":40,"state":31,"zip":41,"country":42,"countryCode":31,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Seoul","05030","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":31,"phoneExt":31,"email":31},"In Ae Kim, M.D. Ph.D.",{"type":25,"investigatorFullName":24,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Professor",[55],{"name":56,"class":57},"Yuhan Corporation","INDUSTRY","100475292","phase-2-neoadjuvant-lazertinib-therapy-in-egfr-mutation-positive-lung-adenocarcinoma-detected-by-balf-liquid-biopsy-100475292",false,"NCT05469022","Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy","A Phase II, Single-Center, Single-Arm, Prospective Study of Neoadjuvant Lazertinib Therapy in Resectable EGFR-Mutation Positive Lung Adenocarcinoma Patients Detected by Broncho-alveolar Lavage Fluid(BALF) Liquid Biopsy","Inclusion Criteria:\n\n1. Age ≥ 19 years\n2. Patients with suspected lung cancer on chest CT findings\n3. Patients with the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)\n4. Patients whose tumor can be completely resected by surgery: patients with stage I-IIIB, or stage IVA who has single metastasis\n5. Patients not previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib\n6. Patients with the measurable lesion of 1 cm or more according to RECIST v1.1\n7. Eastern Cooperative Oncology Group (ECOG) 0-1\n8. EGFR-TKIs (gefitinib, erlotinib, afatinib,dacomitinib) naive patients\n9. Patients with adequate pulmonary and heart function for surgery\n10. Adequate organ function defined as Hemoglobin ≥ 9.0g\u002FdL Absolute neutrophil count ≥ 1500\u002Fmm3 Platelet ≥ 100,000 \u002Fmm3 Serum creatinine≤ normal range\\*1.5x Aminotransferase\u002FAlkaline phosphatase ≤normal range\\*2.5x Total bilirubin ≤1.5 mg\u002FdL Liver metastasis: Aminotransferase\u002FAlkaline phosphatase ≤ normal range\\* 5x Bone metastasis Alkaline phosphatase ≤ normal range\\* 5x\n11. Female patients with childbearing potential should be using adequate contraceptive measures. Female patients must have evidence of non-child-bearing potential(Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments)\n12. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 3 months following the last dose of Lazertinib.\n\nExclusion Criteria:\n\n1. Uncontrolled active interstitial lung disease\n2. Pathologically confirmed N3 disease\n3. Uncontrolled stage III-IV other malignancy\n4. Uncontrolled Hypertension, Congestive Heart failure with New York Heart Association(NYHA) ≥ 3, acute myocardial infarct history within 6 months before screening. 2nd- 3rd Atrio-Ventricular(AV) block or complete AV block\n5. Gastrointestinal diseases (e.g. Chron's disease, ulcerative colitis) or malabsorption syndrome that would impact on drug absorption\n6. Active infection requiring ongoing treatment(e.g. active Hepatitis B virus, Hepatitis C virus or Human immunodeficiency virus)\n7. History of hypersensitivity to active or inactive excipients of Lazertinib or drugs with a similar chemical structure.\n8. No ability to comply with protocol requirements.","ALL","19 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate. The efficacy of neoadjuvant treatment by first-generation EGFR-Tyrosine Kinase Inhibitor(TKI) has been demonstrated, however, that of the third-generation EGFR-TKI(lazertinib) has not yet been fully investigated. The aim of this study is to evaluate the efficacy of neoadjuvant Lazertinib in resectable EGFR mutation-positive NSCLC and clinical application of extracellular vesicles(EVs) based BALF liquid biopsy to identify EGFR mutation without invasive tissue biopsy.",[75],"Non Small Cell Lung Cancer",[77,78,79,80,81],"EGFR mutation","extracellular vesicle","bronchoalveolar lavage","liquid biopsy","lazertinib","2022-07-20",{"date":84,"type":85},"2022-07-21","ACTUAL",{"date":87,"type":85},"2022-05-19",{"date":89,"type":69},"2027-05-19",{"name":5,"class":6},1]