None listed
Conditions
Interventions
Vial 1200 mg/20 ml. of atezolizumab solution, The dose of atezolizumab in this study will be 1200 mg administered by intravenous infusion every 3 weeks (21 [± 3] days).
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: Age ≥ 18 years, *Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that: 1) has been treated with one line of standard systemic chemotherapy (with or without an additional line of targeted therapy) or one line of anti-PD-1 therapy (with or without an additional line of standard systemic chemotherapy), and 2) has recurred and is currently progressing. *ECOG performance status 0, 1, or 2 *Life expectancy ≥ 12 weeks. *Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1. *Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible.
Exclusion criteria
Exclusion criteria: 1.Symptomatic CNS metastases. 2.Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to randomization. 3.Leptomeningeal disease.4.Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures 5.Pregnant or lactating, or intending to become pregnant during the study. 6.Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina. 7.Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
Countries
Argentina, Argeria, Brazil, China, Colombia, Costa Rica, Denmark, Egypt, Greece, Guatemala, Italy, Latovia, Lebano, Malasya, Mexico, Morocco, Norway, Panama, Peru, Philippines, Poland, Slovenia, Spain, Sweden, United Arab Emirates, United Kindgdom
Contacts
Public ContactLeslie Kikushima
ROCHE FARMA (PERU) S.A.
Outcome results
None listed