Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Atezolizumab
INN of investigational material : atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investig
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -18 years or older -Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 -Histologically or cytologically confirmed, treatment-naive Stage IV squamous NSCLC -Previously obtained archival tumor tissue or tissue obtained from biopsy at screening -Measurable disease as defined by RECIST v1.1 -Adequate hematologic and end organ function
Exclusion criteria
Exclusion criteria: -Active or untreated central nervous system (CNS) metastasis -Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated -with expected curative outcome -Pregnant or lactating women -History of autoimmune disease -History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on -screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted -Positive test for Human Immunodeficiency Virus (HIV) -Active hepatitis B or hepatitis C -Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti PD-1, and anti-PD-L1 therapeutic antibody -Severe infection within 4 weeks prior to randomization -Significant history of cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy progression-free survival, Overall survival RECIST v1.1, Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Objective response rate RECIST v1.1 | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed