drugset / Trial / NCT06554613

Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC

NCT06554613

Phase 2 Recruiting 156 enrolled Second Affiliated Hospital of Nanchang University
RandomizedParallel-groupOpen-labelTreatment

Summary

Clinical Trial The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. The main questions it aims to answer are: Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone? What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors? Participants will: Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months. Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends. Keep a record of their symptoms and disease progression.

Timeline

Start
2024-07-02
Primary completion
2026-12-01
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 5 mg Oral
Background Nivolumab Monoclonal antibody 2 mg/kg Intravenous