OncoMatch/Clinical Trials/NCT07633626
Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
Is NCT07633626 recruiting? Yes, currently enrolling (Jul 2026).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK fusion
Required: ROS1 fusion
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: ALK inhibitor (lorlatinib) — standard therapeutic regimen
Currently receiving lorlatinib as part of the standard therapeutic regimen
Cannot have received: vortioxetine (vortioxetine)
Prior vortioxetine use
Lab requirements
Kidney function
not severe impairment
Liver function
not severe impairment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07633626 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior vortioxetine disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify