NCT07633626Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 10 Mar 2026
- Primary completion date
- 10 Mar 2027
- Lead sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- Diseases
- Lung cancer
- NCT number
- NCT07633626
What you commit to
- Study type: Observational
- Planned participants: 24
- From 10 Mar 2026 to the primary completion date, 10 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of major cognitive impairment unrelated to cancer treatment.
- Contraindications to vortioxetine (e.g., concomitant MAOI use).
- Prior vortioxetine use.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic Coordinator of this site? Confirm its status | Bogota | Colombia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.