Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT07633626 · last updated 2026-06-08