Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
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: -Active or untreated CNS metastases -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 cluster of CD137 agonists or immune checkpoint blockade therapies, anti-PD1, and anti-PD-L1 therapeutic antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Obserbation, RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics safety Obserbation, RECIST v1.1 | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America