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

NCT07633626 | Recruiting

• 1 other identifier: Vortioxetina
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• Psychomotor Speed

  Digit Symbol Substitution Test (DSST). The DSST measures psychomotor speed and sustained attention. Participants match symbols to digits within a fixed time limit. Score range: 0 to 90 (number of correct substitutions in 90 seconds); higher scores indicate better cognitive performance. Within-subject change from baseline analyzed using ANCOVA.

  Baseline, Week 6, Week 12

• Processing Speed and Visual Attention

  Trail Making Test Part A (TMT-A). The TMT-A measures processing speed and visual scanning. The outcome is time to completion in seconds; lower scores indicate better performance. Clinically meaningful change assessed using the Reliable Change Index (RCI).

  Baseline, Week 6, Week 12

• Executive Function and Cognitive Flexibility

  Trail Making Test Part B (TMT-B). The TMT-B measures executive function and set-shifting ability. The outcome is time to completion in seconds; lower scores indicate better performance. Clinically meaningful change assessed using the Reliable Change Index (RCI).

  Baseline, Week 6, Week 12

• Selective and Sustained Attention

  D2-R Test of Attention. The D2-R Test of Attention measures selective and sustained visual attention. The primary metric is the Total Concentration Performance score (TN-E), calculated as total items processed minus errors. Score range: 0 to 299; higher scores indicate better attentional performance.

  Baseline, Week 6, Week 12

• Working Memory

  Wechsler Adult Intelligence Scale IV (WAIS-IV), Working Memory Index. The WAIS-IV Working Memory Index is a standardized composite score derived from Digit Span and Arithmetic subtests. Score range: 45 to 155 (mean 100, SD 15); higher scores indicate better working memory capacity. Change from baseline analyzed using linear mixed-effects models (LMM).

  Baseline, Week 6, Week 12

• Processing Speed

  Wechsler Adult Intelligence Scale IV (WAIS-IV), Processing Speed Index. The WAIS-IV Processing Speed Index is a standardized composite score derived from Coding and Symbol Search subtests. Score range: 45 to 155 (mean 100, SD 15); higher scores indicate better processing speed. Change from baseline analyzed using LMM.

  Baseline, Week 6, Week 12

• Verbal Learning and Memory

  California Verbal Learning Test (CVLT). The California Verbal Learning Test measures verbal learning and episodic memory across five immediate recall trials plus short- and long-delay recall. Primary metric: Total Learning Trials 1-5 (score range: 0 to 80); higher scores indicate better verbal memory performance.

  Baseline, Week 6, Week 12

• Language

  Phonemic Verbal Fluency Task. Phonemic verbal fluency is measured by the total number of words beginning with a specified letter generated in 60 seconds. There is no fixed maximum; higher scores indicate better phonemic language production and frontal-executive function. The average of three letter trials (F, A, S) will be reported.

  Baseline, Week 6, Week 12

• Language

  Semantic Verbal Fluency Task. Semantic verbal fluency is measured by the total number of words from a specified semantic category generated in 60 seconds. There is no fixed maximum; higher scores indicate better semantic retrieval and language functioning.

  Baseline, Week 6, Week 12

• Frontal Lobe and Executive Function

  INECO Frontal Screening (IFS). The INECO Frontal Screening (IFS) evaluates frontal lobe functions including motor programming, verbal fluency inhibitory control, working memory, abstraction capacity, and reflex suppression. Score range: 0 to 30; higher scores indicate better executive and frontal lobe functioning.

  Baseline, Week 6, Week 12

• Subjective Cognitive Complaints

  Perceived Deficits Questionnaire (PDQ), Attention/Concentration Subscore. The PDQ Attention/Concentration subscore measures self-reported cognitive difficulties in attention and concentration. Subscore range: 0 to 20; higher scores indicate greater perceived cognitive impairment. Analyzed using mixed models for repeated measures (MMRM).

  Baseline, Week 6, Week 12

• Subjective Cognitive Complaints

  Perceived Deficits Questionnaire (PDQ), Planning/Organization Subscore. The PDQ Planning/Organization subscore measures self-reported difficulties in planning and organizational ability. Subscore range: 0 to 20; higher scores indicate greater perceived impairment. Analyzed using MMRM.

  Baseline, Week 6, Week 12

• Clinical Global Impression of Improvement (CGI-I)

  The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician-rated measure of overall clinical improvement relative to baseline. Score range: 1 (very much improved) to 7 (very much worse); lower scores indicate greater improvement. Response is defined as a score of 1 or 2. Analyzed using MMRM.

  Baseline, Week 6, Week 12

Secondary Outcomes (12)

• Depressive Symptoms

  Baseline, Week 6, Week 12, Month 6

• Depressive Symptoms

  Baseline, Week 6, Week 12

• Health-Related Quality of Life

  Baseline, Month 1, 2, 3, 6, 12

• Health-Related Quality of Life

  Baseline, Month 1, 2, 3, 6, 12

• Life Satisfaction

  Baseline, Month 1, 2, 3, 6, 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (\>= 18 years) with histologically confirmed advanced (stage IIIB/IV) lung adenocarcinoma harboring ALK or ROS1 fusions, currently receiving lorlatinib as standard care, and initiating vortioxetine for NAE management.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Bogotá, 110131, Colombia

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Felipe Canro, MD

CONTACT

+57 310 8593083; felipe.canro@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: June 8, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CO (1)