Vortioxetine for cognitive problems in ALK/ROS1-positive NSCLC treated with lorlatinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study enrolling 24 adults with ALK/ROS1-positive NSCLC who are on lorlatinib and have lorlatinib-related neurocognitive adverse events. Participants will receive vortioxetine (10–20 mg/day) as part of standard care and undergo neuropsychological testing and quality-of-life assessments at baseline and during follow-up. Researchers will track changes in cognitive function and patient-reported outcomes to see if vortioxetine provides benefit. The study describes real-world use without a randomized control group, focusing on safety and potential cognitive improvements. Eligibility requires confirmed ALK/ROS1-positive NSCLC, current lorlatinib treatment, and capacity to complete assessments in Spanish.

Why it matters

Who can join: the full rules

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's running

• Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC
  Bogotá, Colombia Recruiting

Study contacts

• Study coordinator: Felipe Canro, MD
• Email: felipe.canro@gmail.com
• Phone: +57 310 8593083

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.