NCT07633626 Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
| NCT ID | NCT07633626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo |
| Condition | Advanced ALK/ROS1-positive NSCLC |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2027-03-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2026-03-10 with a primary completion date of 2027-03-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07633626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced ALK/ROS1-positive NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07633626 currently recruiting?
Yes, NCT07633626 is actively recruiting participants. Contact the research team at felipe.canro@gmail.com for enrollment information.
Where is the NCT07633626 trial being conducted?
This trial is being conducted at Bogotá, Colombia.
Who is sponsoring the NCT07633626 clinical trial?
NCT07633626 is sponsored by Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo. The trial plans to enroll 24 participants.