Lung cancer
Conditions
Interventions
1200 mg of Atezolizumab is administered by intravenous infusion once every 3 weeks(q3w)
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed, Stage 3B/4or recurrent NSCLC 2) Available biopsy lesion prior to study treatment The following is also acceptable, aspiration biopsy, brushing, cell pellet from pleural effusion 3) Patients who have received platinum-based chemotherapy to NSCLC, and confirmed aggravation during or after treatment In addition, ?patients with EGFR mutations confirmed PD/ not tolerable by treatment of TKI ?patients with ALK fusion gene confirmed PD/ not tolerable by treatment of ALK inhibitor
Exclusion criteria
Exclusion criteria: 1)Patients undergoing any approved anti-cancer therapy, including chemotherapy or hormonal therapy within 3 weeks prior to registration. The following are exceptions, ?Hormone replacement therapy ?Oral contraceptive 2) Patients treated with an investigational agent within 28 days or participated in other clinical trial. 3) History of allergic reactions to Chinese Hamster Ovary(CHO)cell-derived biopharmaceuticals or ingredient of Atezolizumab 4) Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody 5) Treatment with systemic immunostimulatory agents (ex.Interferons, interleukin-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to registration 6)Treatment with systemic immunosuppressive medications (ex. prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 14 days prior to registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate: ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate: DCR Progression free survival: PFS Overall survival: OS Incidence of Adverse Events | — |
Countries
Japan
Contacts
Public ContactKeisuke Kirita
National Cancer Center Hospital East Department of Thoracic Oncology
Outcome results
None listed