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

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT06554613

Run by

Second Affiliated Hospital of Nanchang University

People needed

156

Starts

2024-07-02

Expected to finish

2027-05-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Staged as Stage IV according to the TNM system.
• Histologically or cytologically confirmed EGFR mutation-negative non-small cell lung cancer.
• Has not received systemic antitumor treatment, and is intended to receive monotherapy or combined chemotherapy with a PD-1/PD-L1 inhibitor as first-line treatment.
• Normal major organ function, that is, meeting the following criteria: (1) Hematological examination criteria must be met: Hb≥90 g/L; ANC≥1.5×10\^9/L; PLT≥80×10\^9/L. (2) Biochemical examination must meet the following criteria: TBIL<1.5×ULN; ALT and AST<2.5×ULN; serum Cr≤1.25×ULN or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula).
• Women of childbearing age must have taken reliable contraceptive measures and have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization.

You may not qualify if…

• Have received any of the following treatments:
• 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;
• Within 7 days prior to the first administration of the study drug, used strong inhibitors or inducers of CYP3A4.
• Subjects with concurrent other malignant tumors, except for basal cell carcinoma of the skin and in situ cancer.
• Subjects with uncontrollable malignant pleural effusion and pericardial effusion.
• Subjects allergic to contrast agents for CT and MRI or any subjects who cannot tolerate MRI examination.
• As judged by the investigator, any serious or poorly controlled systemic diseases, such as uncontrolled hypertension, active bleeding diathesis, or active infection.
• Clinically severe gastrointestinal functional abnormalities that may affect the intake, transport, or absorption of the drug, such as the inability to take oral medication, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, unresolved recurrent diarrhea, atrophic gastritis, gastric diseases requiring long-term use of proton pump inhibitors, Crohn's disease, ulcerative colitis, etc.
• Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis.
• Meet any of the following cardiac examination results:
• The average of the corrected QT interval (QTcF) obtained from three ECG examinations at rest is > 470 msec;
• Resting ECG suggests conduction or ECG morphological abnormalities (such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval > 250 msec, etc.);
• There are any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concurrent medication of unexplained sudden death in direct relatives under the age of 40 or prolonged QT interval;
• Left ventricular ejection fraction (LVEF) < 50%.
• Insufficient bone marrow reserve or organ function, reaching any of the following laboratory limits:
• Absolute neutrophil count <1.5×10\^9/L;
• Platelet count <100×10\^9/L;
• Hemoglobin <90 g/L (<9 g/dL);
• If there is no definite liver metastasis, alanine aminotransferase > 3 times the upper limit of normal (ULN); if there is liver metastasis, alanine aminotransferase > 5×ULN;
• If there is no definite liver metastasis, aspartate aminotransferase >3×ULN; if there is liver metastasis, aspartate aminotransferase > 5×ULN;
• If there is no definite liver metastasis, total bilirubin > 1.5×ULN; or with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastasis, total bilirubin > 3×ULN;
• Creatinine > 1.5×ULN and creatinine clearance <50 mL/min (calculated by the Cockcroft-Gault formula); creatinine clearance is only required if creatinine > 1.5×ULN;

Where it is running

• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)

Full record on ClinicalTrials.gov

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