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NOT YET RECRUITING
NCT06554613
PHASE2

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

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

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.

Official title: An Open-label, Two-arm, Multicenter, Phase II Randomized Controlled Trial Assessing the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients With Advanced EGFR Mutation-negative Non-small Cell Lung Cancer (NSCLC).

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2024-12-01

Completion Date

2028-05-31

Last Updated

2024-08-15

Healthy Volunteers

No

Interventions

DRUG

Olanzapine

Olanzapine 5mg qd (once daily), q3w(every 3 weeks), oral therapy,Administered continuously for 6-8 weeks.

DRUG

Nivolumab

Nivolumab,Infused intravenously once every 3 weeks at a dose of 2mg/kg, with a continuous 21-day treatment period constituting one treatment cycle.