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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Jun 8, 2026

Start date

Mar 10, 2026

Status verified

Jun 2026

Primary completion

Mar 10, 2027

Completion

Nov 10, 2027

Study Design

Enrollment

24 participants (estimated)

Primary Outcome Measure

Psychomotor Speed [ Time Frame: Baseline, Week 6, Week 12 ]

Central Contacts

• Felipe Canro, MD
  +57 310 8593083
  [email protected]

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