[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575463":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":34,"acronym":19,"eligibilityCriteria":35,"healthyVolunteers":32,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":19,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":51,"overallStatus":55,"whyStopped":19,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":19},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.",[13],"Drug: Ensartinib group",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Ensartinib group",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Li Wang, MD","CONTACT","1817021997","leewang8023@126.com",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Chunxia Su","Director of Clinical Research Center, Shanghai Pulmonary Hospital","100575463","phase-2-the-efficacy-and-safety-of-ensartinib-as-adjuvant-therapy-in-stage-i-alk-positive-nsclc-patients-with-high-risk-factors-100575463",false,"NCT06772610","The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors","Inclusion Criteria:\n\n* Aged 18-75 years;\n* ECOG performance status 0-1;\n* Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;\n* Confirmed ALK fusion-positive by FISH, IHC, or NGS;\n* No prior systemic treatment after surgery;\n* At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;\n* Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;\n* Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g\u002FL; Absolute neutrophil count ≥1.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL\u002Fmin;\n* Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;\n* Informed consent obtained from the patient or their legal representative;\n* Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.\n\nExclusion Criteria:\n\n* Previous systemic treatment for NSCLC;\n* Previous local radiotherapy for NSCLC;\n* Unable to take oral medications;\n* Known allergy to Ensartinib or any component of this product;\n* History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;\n* Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;\n* Pregnant or breastfeeding women;\n* History of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Any other conditions that the investigator deems unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":40,"type":41},40,"ESTIMATED","INTERVENTIONAL",[44],"PHASE2","This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.",[47,48,49,50],"NSCLC","ALK","Stage I","Adjuvant Treatment",[47,52,53,54],"ALK positive","adjuvant treatment","high-risk factors","NOT_YET_RECRUITING","2025-01-10",{"date":58,"type":59},"2025-01-13","ACTUAL",{"date":61,"type":41},"2025-03-15",{"date":63,"type":41},"2032-03-31",{"name":5,"class":6}]