Actively Recruiting
Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
Led by Second Affiliated Hospital of Nanchang University · Updated on 2026-05-05
156
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old (inclusive)
- Confirmed advanced EGFR mutation-negative non-small cell lung cancer
- Stage IV disease according to TNM system
- ECOG performance status 0 to 2
- Expected survival of at least 3 months
- No prior systemic antitumor treatment
- Planned first-line treatment with PD-1/PD-L1 inhibitors alone or with chemotherapy
- Normal major organ function meeting specified blood and biochemical criteria
- Women of childbearing age must use reliable contraception and have a negative pregnancy test within 7 days before enrollment
- Men must agree to use contraception or have surgical sterilization during the study and for 8 weeks after last dose
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Previous treatment with EGFR tyrosine kinase inhibitors, chemotherapy, or radiotherapy for lung cancer (except palliative bone radiotherapy)
- Major surgery within 4 weeks before starting study drug
- Use of strong CYP3A4 inhibitors or inducers within 7 days before starting study drug
- Concurrent other malignant tumors except basal cell carcinoma or in situ cancer
- Uncontrollable malignant pleural or pericardial effusion
- Allergy to contrast agents or intolerance to MRI
- Serious or poorly controlled systemic diseases like uncontrolled hypertension or active bleeding
- Severe gastrointestinal disorders affecting oral medication intake or absorption
- Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis
- Abnormal cardiac findings or increased risk of arrhythmias
- Insufficient bone marrow or organ function based on laboratory values
- Active fungal, bacterial, or viral infections needing systemic treatment
- Pregnancy, breastfeeding, or planning pregnancy during the study
- History or active interstitial lung disease or radiation pneumonitis requiring steroids
- Poor compliance potential due to neurological or mental disorders
- Any condition judged by investigators to risk safety or study evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
H
Huang Long, Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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