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

Sponsor
Second Affiliated Hospital of Nanchang University
Study ID
NCT06554613
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 2, 2024
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
May 31, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olanzapine in Combination with Immune Checkpoint Inhibitors Treatment Group
    Receiving first-line treatment with a PD-1/PD-L1 inhibitor as a single agent or in combination with chemotherapy (according to the instructions manual)，Medication is administered on the first day of each cycle, with one cycle every 3 weeks. A continuous 21-day treatment constitutes one treatment cycle.Then receive olanzapine orally at a dose of 5mg once daily (qd), with continuous administration for 6-8 weeks.
  • Active Comparator: Group Without Olanzapine
    Receiving first-line treatment with a PD-1/PD-L1 inhibitor as a single agent or in combination with chemotherapy (according to the instructions manual)，Medication is administered on the first day of each cycle, with one cycle every 3 weeks. A continuous 21-day treatment constitutes one treatment cycle..

Primary Outcome Measure

The Overall Survival（OS） [ Time Frame: 24 months ]

Central Contacts

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