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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants voluntarily enroll in this study and sign an informed consent form, with good compliance and cooperation with follow-up.

Age is over 18 years old (including 18 years old) and under 75 years old (including 75 years old).

ECOG score: 0-2 points.

Expected survival is no less than 3 months.

Disqualifiers

Previously used any EGFR tyrosine kinase inhibitors;

Previously received any chemotherapy for lung cancer;

Previously received any radiotherapy for lung cancer (except palliative radiotherapy for bone metastases);

Within 4 weeks prior to the first administration of the study drug, the subject had undergone major surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olanzapine

    Drug

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

  • Nivolumab

    Drug

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

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Olanzapine in Combination with Immune Checkpoint Inhibitors Treatment GroupExperimental treatment 2 interventions
Group B: Group Without OlanzapineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Overall Survival(OS)

The Overall Survival(OS),From the time of a patient's diagnosis or the commencement of treatment, to the time of the patient's death.

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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