Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer
- Conditions
- on-small cell lung carcinoma
- Registration Number
- JPRN-UMIN000033411
- Lead Sponsor
- Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 112
Not provided
1) Chemotherapy was used in the past 21 days. Exceptionally administration of tyrosine kinase inhibitors are not to be excluded. 2)Patients with symptomatic brain metastases and meningeal metastases. However, clinically stable brain metastasis cases can be registered. 3) Uncontrolled pleural effusion, pericardial effusion, and/or ascites. 4) Uncontrolled hyperkalemia. 5) Active double cancer within 5years of the first day of nivolumab treatment. 6) Pregnant or breast-feeding female patients. 7) Autoimmune disease. 8) Evident pulmonary fibrosis, organized pneumonia, drug-induced pneumonia or interstitial lung disease. Patients with active pneumonia at screening CT. 9) Serum albumin < 2.5g/dl 10) Patients with active infectious disease (HBV hepatitis, tuberculosis, pneumonia, sepsis etc.) 11) Ptients with serious heart disease. 12) Attenuated live vaccine within 4 weeks of the first dose of nivolumab, or suppose to be needed during the treatment. 13) Immunostimulant (INF, IL-2, etc) within 6 weeks. 14) Immunosuppressant (predonisoron, cyclophosphamide, azathioprine, methotrexate, etc) within 2 weeks.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival after administration of nivolumab with respect to immune-related gene SNPs.
- Secondary Outcome Measures
Name Time Method Immune-related adverse events after administration of nivolumab with respect to immune-related gene SNPs.