Extensive-stage 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: - Histologically or cytologically confirmed ES-SCLC - No prior treatment for ES-SCLC - ECOG performance status of 0 or 1 - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end organ function
Exclusion criteria
Exclusion criteria: - Malignancies other than SCLC within the last 5 years - 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 CT scan. - Positive test for Human Immunodeficiency Virus (HIV) - Active hepatitis B or hepatitis C - Severe infections at the time of enrollment - Significant cardiovascular disease - Prior treatment with immune checkpoint blockade therapies, anti-PD1 and anti-PD-L1 therapeutic antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Observation, RECIST v1.1, Inspection | — |
Countries
Asia except Japan, Japan
Outcome results
None listed