[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-i":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"NSCLC","ALK","Stage I","Adjuvant Treatment",[26,31,32,33],"ALK positive","adjuvant treatment","high-risk factors","NOT_YET_RECRUITING","2025-01-10",{"date":37,"type":38},"2025-01-13","ACTUAL",{"date":40,"type":20},"2025-03-15",{"date":42,"type":20},"2032-03-31",{"name":44,"class":45},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER"]