[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-alkros1-positive-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-alkros1-positive-nsclc":24},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100643034","vortioxetine-for-cognitive-function-in-alk-positive-nsclc-treated-with-lorlatinib-100643034",false,"NCT07633626","Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib","Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ALK\u002FROS1-positive non-small cell lung cancer (NSCLC), stage IIIB\u002FIV.\n* Currently receiving lorlatinib as part of the standard therapeutic regimen.\n* Documented neurocognitive adverse events (NAEs) attributable to lorlatinib.\n* Age \\>= 18 years.\n* ECOG performance status 0-2.\n* Ability to understand and sign informed consent.\n* Expected survival \\>= 6 months.\n* Planned initiation of vortioxetine as part of standard care.\n* Ability to complete neuropsychological tests and questionnaires in Spanish.\n\nExclusion Criteria:\n\n* Prior diagnosis of major cognitive impairment unrelated to cancer treatment.\n* Current use of another antidepressant that cannot be discontinued.\n* Uncontrolled major psychiatric disorder.\n* History of uncontrolled epilepsy or recent seizures.\n* Severe hepatic or renal impairment.\n* Known hypersensitivity to vortioxetine.\n* Participation in another clinical trial within the past 30 days.\n* Inability to provide informed consent.\n* Life expectancy \\\u003C 3 months.\n* Contraindications to vortioxetine (e.g., concomitant MAOI use).\n* Prior vortioxetine use.\n* Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","OBSERVATIONAL","This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.\n\nLorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.\n\nTwenty-four adult patients with ALK\u002FROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg\u002Fday) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.",[24,25,26,27,28,29],"Advanced ALK\u002FROS1-positive NSCLC","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Adenocarcinoma","ALK-positive Non-small Cell Lung Cancer (NSCLC)","Cognitive Dysfunction","Depression","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-08","ACTUAL",{"date":36,"type":34},"2026-03-10",{"date":38,"type":20},"2027-11-10",{"name":40,"class":41},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER"]