A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
- Trial number:
-
NCT04256421
- Trial phase:
- 3
- Study type:
- Immunotherapy, Chemotherapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
- 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
- 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 within 28 days prior to initiation of study treatment - 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
Study design
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