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Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib

Recruitingn/aAges 18 Years - anyAllCentro de Tratamiento e Investigación sobre Cánce…
NCT07633626 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Lorlatinib 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. Twenty-four adult patients with ALK/ROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg/day) for NAE management will be enrolled. Comprehensive

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed diagnosis of ALK/ROS1-positive non-small cell lung cancer (NSCLC), stage IIIB/IV. * Currently receiving lorlatinib as part of the standard therapeutic regimen. * Documented neurocognitive adverse events (NAEs) attributable to lorlatinib. * Age \>= 18 years. * ECOG performance status 0-2. * Ability to understand and sign informed consent. * Expected survival \>= 6 months. * Planned initiation of vortioxetine as part of standard care. * Ability to complete neuropsychological tests and questionnaires in Spanish. Exclusion Criteria: * Prior diagnosis of major cognitive impairment unrelated to cancer treatment. * Current use of another antidepressant that cannot be discontinued. * Uncontrolled major psychiatric disorder. * History of uncontrolled epilepsy or recent seizures. * Severe hepatic or renal impairment. * Known hypersensitivity to vortioxetine. * Participation in another clinical trial within the past 30 days. * Inability to provide informed consent. * Life expectancy \< 3 months. * Contraindications to vortioxetine (e.g., concomitant MAOI use). * Prior vortioxetine use. * Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.
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What it tests

  • Not listed
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Where

1 site
Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC
Bogotá, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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