Pretreated Non-small cell lung cancer
Conditions
Interventions
biweekly 3mg/kg nivolumab treatment
Sponsors
Kindai university, Faculty of Medicine, Department of Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven diagnosis of non-small cell lung cancer. 2)Disease recurrence or progression during/after one prior chemotherapy regimen (including EGFR-TKI and ALK-TKI) for advanced or metastatic disease 3)Able to collect blood samples and tumor tissues before treatment. 4)Men and women above 20 years of age 5)Eastern Cooperative Oncology Group (ECOG) performance status below 2 6)Evaluable disease, or measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria 7)Adequate bone marrow function (hemoglobin above; 9.0 mg/dL; platelets above; 100 x 109/L; WBC above 2.0 X 109/L ANC above; 1.5 X 109/L without the use of hematopoietic growth factors) 8)Adequate renal function (creatinine below; 1.5 X ULN [upper limit of normal]). 9)Adequate hepatic function (total bilirubin below; 1.5 X ULN for the institution; AST [aspartate transaminase] and ALT [alanine transaminase] below; 3.0 X ULN). 10)Able to understand and give written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: Subjects with untreated symptomatic CNS metastases are excluded. 2 Symptomatic carcinomatous meningitis 3 Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism 4 Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 5 Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 6 Subjects with interstitial lung disease 7 Treatment with any investigational agent within 14 days of first administration of study treatment 8 Known history of stroke or cerebrovascular accident within 6 months prior to the enrollment 9 Subjects with known infection with HIV or AIDS 10 Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection 11 Any evidence of serious active infections. 12 Cancer directed therapy within 28 days of the first dose of nivolumab. 13 Major surgery within 28 days prior to the first dose of nivolumab.14 Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, NYHA Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.15 Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness social situations that would limit compliance with study requirements. 16 Subjects with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.17 Women who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the relationship between the biomarker candidate and 6 months PFS rate. | — |
Countries
Japan
Contacts
Public ContactHidetoshi Hayashi
Kindai university, Faculty of Medicine Department of Medical Oncology
Outcome results
None listed