[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559428":3},{"organization":4,"armGroups":7,"interventions":54,"overallOfficials":107,"centralContacts":112,"locations":117,"responsibleParty":136,"collaborators":94,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":141,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":94,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":120,"whyStopped":94,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14,19,24,29,34,39,44,49],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment 1-Sunvozertinib","EXPERIMENTAL","Patients with EGFR exon20ins mutation receive Sunvozertinib 300 mg orally once a day, 28 days as one cycle for 3 cycle.",[13],"Drug: Sunvozertinib",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment 2-Crizotinib","Patients with ROS1 fusion mutation receive Crizotinib 250mg orally once a day, 28 days as one cycle for 3 cycle.",[18],"Drug: Crizotinib",{"label":20,"type":10,"description":21,"interventionNames":22},"Treatment 3-Pralsetinib","Patients with RET fusion mutation receive Pralsetinib 400mg orally once a day, 28 days as one cycle for 3 cycle.",[23],"Drug: Pralsetinib",{"label":25,"type":10,"description":26,"interventionNames":27},"Treatment 4-Larotrectinib","Patients with NTRK fusion mutation receive Larotrectinib 100 mg orally twice daily, 28 days as one cycle for 3 cycle.",[28],"Drug: Larotrectinib",{"label":30,"type":10,"description":31,"interventionNames":32},"Treatment 5-Savolitinib","Patients with MET 14 exon mutation receive Savolitinib 600 mg or 400 mg (weight \\\u003C50 kg) orally once a day, 28 days as one cycle for 3 cycle.",[33],"Drug: Savolitinib",{"label":35,"type":10,"description":36,"interventionNames":37},"Treatment 6-Pyrotinib","Patients with HER2 mutation receive Pyrotinib 400 mg orally once a day, 28 days as one cycle for 3 cycle.",[38],"Drug: Pyrotinib",{"label":40,"type":10,"description":41,"interventionNames":42},"Treatment 7-Dabrafenib+Trametinib","Patients with BRAF V600E mutation receive Dabrafenib plus Trametinib, 28 days as one cycle for 3 cycle.",[43],"Drug: Dabrafenib+Trametinib",{"label":45,"type":10,"description":46,"interventionNames":47},"Treatment 8-Glecirasib","Patients with KRAS G12C mutation receive Glecirasib 800 mg daily orally, 28 days as one cycle for 3 cycle.",[48],"Drug: Glecirasib",{"label":50,"type":10,"description":51,"interventionNames":52},"Treatment 9-Ensartinib","Patients with ALK fusion mutation receive Ensartinib 225 mg daily orally, 28 days as one cycle for 3 cycle.",[53],"Drug: Ensartinib",[55,62,67,73,79,85,90,95,101],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","Sunvozertinib","300 mg orally once a day, 28 days as one cycle.",[9],[61],"DZD9008",{"type":56,"name":63,"description":58,"armGroupLabels":64,"otherNames":65},"Crizotinib",[15],[66],"Xalkori",{"type":56,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Pralsetinib","400 mg orally once a day, 28 days as one cycle.",[20],[72],"GAVRETO",{"type":56,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Larotrectinib","100 mg orally twice daily, 28 days as one cycle.",[25],[78],"VITRAKVI",{"type":56,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Savolitinib","600 mg or 400 mg (weight \\\u003C50 kg) orally once a day, 28 days as one cycle.",[30],[84],"ORPATHYS",{"type":56,"name":86,"description":69,"armGroupLabels":87,"otherNames":88},"Pyrotinib",[35],[89],"SHR1258",{"type":56,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"Dabrafenib+Trametinib","Dabrafenib 150 mg orally twice daily, 28 days as one cycle. Trametinib 150 mg orally twice daily, 28 days as one cycle.",[40],null,{"type":56,"name":96,"description":97,"armGroupLabels":98,"otherNames":99},"Glecirasib","800 mg daily orally, 28 days as one cycle.",[45],[100],"JAB-21822",{"type":56,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"Ensartinib","225 mg daily orally, 28 days as one cycle.",[50],[106],"X-396",[108],{"name":109,"affiliation":110,"role":111},"Si-Yu Wang, MD","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[113],{"name":109,"role":114,"phone":115,"phoneExt":94,"email":116},"CONTACT","+86 20 87343439","wangsy@sysucc.org.cn",[118],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":127,"coordinates":128},"Point",[129,130],113.25,23.11667,{"lat":130,"lon":129},[133],{"name":134,"role":114,"phone":115,"phoneExt":94,"email":135},"Si-Yu Wang, Doctor","wsysums@163.net",{"type":111,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":94,"oldOrganization":94},"Si-Yu Wang","Professor","100559428","phase-2-neoadjuvant-umbrella-trial-for-patients-with-unresectable-stage-iii-nsclc-harboring-rare-mutations-100559428",false,"NCT06563999","Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.","Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)","NUMER","Inclusion Criteria:\n\n* Subjects must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging;\n* Squamous or non-squamous NSCLC histology;\n* Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion.\n* Subjects should be without EGFR exon 19 deletions or exon 21 L858R activating mutation;\n* Male and female, aged 18-75 years;\n* Blood and specimens before and after treatment must be provided;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n* Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109\u002FL, and Platelet count ≥100 x 109\u002FL, and Hemoglobin ≥9 g\u002FdL (may be transfused to maintain or exceed this level);\n* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;\n* Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml\u002Fmin;\n* Female subjects should not be pregnant or breast-feeding;\n* Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study.\n\nExclusion Criteria:\n\n* Not unresectable stage III disease according to the investigator;\n* Subjects with known EGFR sensitive mutations;\n* Previous treatment with systemic antitumor therapy for NSCLC;\n* Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.\n* History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.\n* Evidence of clinically active interstitial lung disease;\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);\n* Inability to comply with protocol or study procedures;\n* Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);\n* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results;\n* Women who are pregnant or nursing.\n* Ingredients mixed with small cell lung cancer patients.","ALL","18 Years","75 Years",{"count":151,"type":152},120,"ESTIMATED","INTERVENTIONAL",[155],"PHASE2","This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.",[158,159],"Lung Cancer Stage III","Mutation",[161,162,163,164],"stage III NSCLC","rare mutations","umbrella trial","neoadjuvant","2026-04-19",{"date":167,"type":168},"2026-04-21","ACTUAL",{"date":170,"type":168},"2024-11-01",{"date":172,"type":152},"2029-11-01",{"name":5,"class":6},1]