RecruitingPhase 2NCT06554613

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

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).


Sponsor

Second Affiliated Hospital of Nanchang University

Enrollment

156 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nivolumab and a drug called Olanzapine for people with non-small cell lung cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlanzapine

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

DRUGNivolumab

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


Locations(1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT06554613


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