Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
Recruiting · NCT07633626 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed.
- Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC - Bogotá, Colombia
- Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC - Bogotá, Colombia