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Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib

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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.

Condition
Advanced ALK/ROS1-positive NSCLC, Carcinoma, Non-Small-Cell Lung (NSCLC), Lung Adenocarcinoma, ALK-positive Non-small Cell Lung Cancer (NSCLC), Cognitive Dysfunction, Depression
Sponsor
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 18 years
  • Study condition: Advanced ALK/ROS1-positive NSCLC, Carcinoma, Non-Small-Cell Lung (NSCLC), Lung Adenocarcinoma, ALK-positive Non-small Cell Lung Cancer (NSCLC), Cognitive Dysfunction, Depression
  • 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 12

  • 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

1 site, 1 recruiting

Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC

Bogotá, Colombia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.