Non-small cell Lung Cancer
Conditions
Interventions
Nivolumab is given at 3 mg/kg intravenously every 2 weeks, and local radiotherapy is performed within 7 days after the previous administration of nivolumab. The timing of the blood sample collection i
before and after radiotherapy, at the point of observing abscopal effect, and at disease progression.
Sponsors
Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Cytologically or histologically confirmed non-small cell lung cancer (2) Stage IV or recurrent diseases without any indications for operation and radical radiotherapy (3) At least one measurable lesions except lung field and suitable for palliative radiotherapy (4) At least one measurable lesions except radiation site (RECIST ver1.1) (5) Patients who have stable or progression disease (determined by at least two consecutive CT scans at 6-week intervals) after 8 weeks or more of nivolumab treatment (6) Aged 20 or more (7) ECOG Performance status of 0-2 (8) Adequate organ function within 2 weeks before study enrolment (9) estimated life expectancy of at least 3 months (10) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Active double cancer(except for some early or cured cancer as followe:carcino ma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer) (2) History of pericardial effusion, pleural effusion, and ascites which drainage treatment is needed (3) patients with clinically disease progression, such as obvious PS deterioration by nivolumab administration (4) radiation field includes the lung (5) Positive serum HBs antigen (6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis (7) Patients with a clinically severe complication (8) History of severe drug allergy (9) women who are or may be pregnant or in lactatoin (10) patients judged to be unsuitable for this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate outside the radiation field | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity, overall survival, progression free survival, survival time related to abscopal effect, disease control rate, abscopal response rate at 4/8 weeks after the complition of radiotherapy, immunological analysis using blood samples | — |
Countries
Japan
Contacts
Public ContactTakayuki Shiroyama
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Department of Thoracic Malignancy
Outcome results
None listed