Advanced non-small cell lung cancer (Stage III/IV or postoperative recurrent)
Conditions
Interventions
Two weeks of the following regimen consist of one course. Administer Nivolumab (240mg) by DIV on day 1, and oral dose of Bezafibrate at 100 mg BID. or 200 mg BID on day 1, 5, 8 and 12, and continue tr
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.confirmed histologically or cytologically as NSCLC 2. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 3.Clinical stage III or IV or postoperative recurrent NSCLC that has been previously treated with at least one cytotoxic drug-included regimen. 4.About patients with NSCLCs harbouring driver oncogenes such as EGFR, they need to have been treated with at least one appropriate TKI. 5. Aged 20 years or older at the time of informed consent. 6. All of the following criteria are met based on the latest data obtained within 14 days before enrollment 1) Leucocyte count >= 2,000/microliter 2) Neutrophil count >= 1,000/microliter 3) Hemoglobin >= 8.0 g/dL (Transfusion is not performed within 14 days before enrollment.) 4) Platelet count >= 10X10^4/microliter 5) Total bilirubin <= 1.5 mg/dL 6) AST (GOT) <= 100 IU/L 7) ALT (GPT) <= 100 IL/L 8) Serum creatinine <=1.5 mg/dL 9) SpO2 >= 92% at room air. Patients with SpO2 < 92% are eligible if PaO2 is >= 60 torr. 7. Able to swallow oral medications.
Exclusion criteria
Exclusion criteria: 1. Patients with an infection requiring systemic treatment. 2. Patients with the history of hypersensitivity to Bezafibrate, Polysorbate 80 that is the component of Nivolumab, and other drugs. 3. Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study. 4. Patients treated with administration of steroid equivalent to more than 10 mg /day predonine, or an immune suppressor (oral or intravenous) within 14 days before enrollment. Patients who do not suffer from current autoimmune diseases and are treated with inhalation or topical administration of steroid or patients with steroid equivalent to more than 10 mg /day predonine as adrenal cortex hormone replacement are eligible. 5. Patients with current or suspicious autoimmune diseases. 6. Patients with symptomatic brain metastases. 7. Patients with carcinomatous meningitis. 8. Active double cancer 9. Patients with unstable angina or poorly controlled hypertension or diabetes mellitus. 10. Patients with positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody. 11. Patients with distinct interstitial pneumonitis or pulmonary fibrosis based on chest CT. 12 Patients whose withdrawal of HMG-CoA inhibitors during this trial are not allowed. 13. Patients with history of previous immune checkpoint inhibitor treatment including Nivolumab. 14. Pregnant or lactating females. Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with dose-limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with at least 1 adverse event Response rate (RR) Progression-free survival (PFS) | — |
Countries
Japan
Contacts
Public ContactIsamu Okamoto
Kyushu University Hospital Research Institute for Diseases of the Chest
Outcome results
None listed