non-small cell lung cancer with bone metastasis
Conditions
Interventions
Radiation therapy 20 Gy/5 fractions to bone metastasis, followed by nivolumab 3mg/kg administered 6 to 24 hours after the end of the radiation therapy. Then, nivolumab is given every two weeks until d
Sponsors
University of Tsukuba Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) a histological or cytological diagnosis of non-small cell lung cancer 2) having bone metastasis suitable for palliative radiation therapy which had not been radiated 3) age above 20 years old 4) ECOG performance status of 0-2 5) Prior platinum-containing chemotherapy 6) Adequate organ function as documented by a WBC count of 3,000/microL or higher, hemoglobin of 9.0 g/dL or higher, platelet count of 100,000/microL or higher, serum creatinine of 1.5 mg/dL or lower, hepatic transaminases of 100 IU/L or lower, alanine aminotransferase of 100 IU/L or lower, total serum bilirubin of 1.8 mg/dL or lower, and PaO2 of 70 Torr or higher or SpO2 of 93% or higher at room air 7) having a measurable disease with CT or MRI 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) Positive for epidermal grow factor receptor activating mutation or ALK re-arrangement 2) Active malignancies within 2 years 3) Active infection requiring intravenous systemic therapy or hospital admission 4) A history of interstitial lung disease 5) A history of active, known autoimmune disease. 6) Requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications. 7) Active CNS metastasis 8) Carcinomatous meningitis 9) Positive for HBs antigen or HBV-DNA positive 10) Positive for HCV antibody 11) Pregnant or breast-feeding women 12) Any other patients whom the doctor judged to be unsuitable for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival, safety, and tolerability | — |
Countries
Japan
Contacts
Public ContactIkuo Sekine
University of Tsukuba Hospitgal Department of Medical Oncology
Outcome results
None listed