Vortioxetine for thinking and memory problems in lung cancer patients taking lorlatinib
Observes if vortioxetine eases thinking problems from lorlatinib in ALK-positive lung cancer.
Plain-language title generated from the registry record
Registry title: Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
Key facts
- Where
- Bogota, ColombiaSee the site
Where in Colombia
- Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo CticBogota, ColombiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- Trial code
- NCT07633626
- Record updated
- 8 June 2026
- Original description
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.Read full original descriptionShow less
Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib
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 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.
Inclusion: 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: Prior diagnosis of major cognitive impairment unrelated to cancer treatment; Contraindications to vortioxetine (e.g., concomitant MAOI use); Prior vortioxetine use; Uncontrolled major psychiatric disorder; History of uncontrolled epilepsy or recent seizures; Severe hepatic or renal impairment; Known hypersensitivity to vortioxetine; Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib; Current use of another antidepressant that cannot be discontinued; Participation in another clinical trial within the past 30 days; Inability to provide informed consent; Life expectancy < 3 months.