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

NCT07633626 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

  • Advanced ALK/ROS1-positive NSCLC
  • Carcinoma, Non-Small-Cell Lung (NSCLC)
  • Lung Adenocarcinoma
  • ALK-positive Non-small Cell Lung Cancer (NSCLC)
  • Cognitive Dysfunction
  • Depression

Sponsors & Collaborators

  • Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2027-03-10
Completion
2027-11-10

Countries

  • Colombia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633626 on ClinicalTrials.gov