previously treated patients with advanced non-small-cell lung cancer
Conditions
Interventions
Collecting pleural effusion and blood before and after Nivolumab treatment
Sponsors
Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically comfarmed non-small-cell lung cancer 2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with pleural effusion that can be taken 3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria. 4)Twenty or more years old at tnetime of imformed consent 5)Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS)0-1 6)Have adequate organ function within 14 days before entry 7)Estimate life expectancy of at least 12 weeks 8)Have signed an informed consent document
Exclusion criteria
Exclusion criteria: 1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray 2)Clinically significant drug allergy 3)Presencee of other active malignancy 4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage 5)Positive serum HBs antigen 6)With severe infection, cardiac diseases, diabates, hypertention, other severe complication 7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks. 8)Pregnancy or lactating patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We study biomarkers in peripheral blood and pleural effusion between before and 2-4 week after Nivolumab treatment start. | — |
Countries
Japan
Contacts
Public ContactHidekazu Suzuki
Osaka Habikino Medical Center Department of Thoracic oncology
Outcome results
None listed