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.
Age range
18 Years
Sex
ALL
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Psychomotor Speed
Timeframe: Baseline, Week 6, Week 12
Processing Speed and Visual Attention
Timeframe: Baseline, Week 6, Week 12
Executive Function and Cognitive Flexibility
Timeframe: Baseline, Week 6, Week 12
Selective and Sustained Attention
Timeframe: Baseline, Week 6, Week 12
Working Memory
Timeframe: Baseline, Week 6, Week 12
Processing Speed
Timeframe: Baseline, Week 6, Week 12
Verbal Learning and Memory
Timeframe: Baseline, Week 6, Week 12
Language
Timeframe: Baseline, Week 6, Week 12
Language
Timeframe: Baseline, Week 6, Week 12
Frontal Lobe and Executive Function
Timeframe: Baseline, Week 6, Week 12
Subjective Cognitive Complaints
Timeframe: Baseline, Week 6, Week 12
Subjective Cognitive Complaints
Timeframe: Baseline, Week 6, Week 12
Clinical Global Impression of Improvement (CGI-I)
Timeframe: Baseline, Week 6, Week 12