JPRN-jRCT2080223248
已完成
3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin plus Etoposide with or without Atezolizumab (Anti-PD-L1 Antibody) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Small Cell Lung Cancer
- 发起方
- CHUGAI PHARMACEUTICAL CO., LTD.
- 入组人数
- 403
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
The addition of atezolizumab to carboplatin and etoposide was associated with significantly longer overall survival and progression-free survival among patients with ES-SCLC, and the safety profile of ACE was consistent with the defined safety risks of the individual agents.
研究者
入排标准
入选标准
- •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
排除标准
- •\-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
结局指标
主要结局
未指定
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