non-small cell lung cancer
Conditions
Interventions
Nivolumab
Sponsors
Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age of 75 years old and older than 75 years old 2)Histologically and/or cytologically proven non-small cell lung cancer 3)Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease. 4)ECOG performance status 0-2. 5)previously treated with systemic chemotherapy 6)Adequate organ function
Exclusion criteria
Exclusion criteria: 1)Subjects with interstitial lung disease which is detected by chest X-ray 3)Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry. 4)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes, Intestinal obstruction. 5)known or suspected autoimmune disease, or receiving continuous systemic corticosteroid or immunosuppressant treatment. 6)Subjects with symptomatic CNS metastases or symptomatic carcinomatous meningitis. Subjects with asymptomatic CNS metastases, and subjects after 4 weeks from whole brain radiation therapy or 2 weeks from stereotactic brain radiation therapy can be included. 7)Radiation therapy within 4 weeks of the first dose of Nivolumab. 8)Subjects with known infection with HIV or AIDS . Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection. 9)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 10)Dementia or psychological disorder difficult to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate progression free survival disease control rate overall survival | — |
Countries
Japan
Contacts
Public ContactYamaguchi Kakuhiro
Hiroshima University Hospital respiratory medicine
Outcome results
None listed