[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643034":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":32,"collaborators":7,"id":34,"slug":7,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":7,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":7,"enrollmentInfo":42,"targetDuration":7,"studyType":45,"phases":7,"briefSummary":46,"conditions":47,"keywords":7,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},{"fullName":5,"class":6},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Felipe Canro, MD","CONTACT","+57 310 8593083","felipe.canro@gmail.com",[15],{"facility":16,"status":17,"city":18,"state":7,"zip":19,"country":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":27},"Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC","RECRUITING","Bogotá","110131","Colombia",{"type":22,"coordinates":23},"Point",[24,25],-74.08175,4.60971,{"lat":25,"lon":24},[28],{"name":29,"role":11,"phone":30,"phoneExt":7,"email":31},"LIliana Gutierrez, RN, MSc","+573003768158","lgutierrez@fctic.org",{"type":33,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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":43,"type":44},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.",[48,49,50,51,52,53],"Advanced ALK\u002FROS1-positive NSCLC","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Adenocarcinoma","ALK-positive Non-small Cell Lung Cancer (NSCLC)","Cognitive Dysfunction","Depression","2026-06-04",{"date":56,"type":57},"2026-06-08","ACTUAL",{"date":59,"type":57},"2026-03-10",{"date":61,"type":44},"2027-11-10",{"name":5,"class":6},1]