Ensayos clínicos

Inclusion Criteria:

• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• No prior systemic treatment for ES-SCLC.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Adequate hematologic and end-organ function.
• Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC.

Exclusion Criteria:

• Symptomatic or actively progressing central nervous system (CNS) metastases.
• Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
• Active or history of autoimmune disease or immune deficiency -History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
• Positive test result for human immunodeficiency virus (HIV).
• Active hepatitis B or hepatitis C.
• Severe infection at the time of randomization.
• Treatment with any other investigational agent with therapeutic intent within 28 days prior to randomization.
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization.