Condition: Advanced ALK/ROS1-positive NSCLC · Carcinoma, Non-Small-Cell Lung (NSCLC) · Lung Adenocarcinoma · Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
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.
This description comes directly from the study's public registry record.
Felipe Canro, MD · +57 310 8593083 · felipe.canro@gmail.com
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| Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC | Bogotá, Colombia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07633626