JPRN-jRCT2080222480已完成3 期
A Randomized Phase 3 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared to Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,225
研究概览
简要总结
This phase 3 study of a PD-L1-directed antibody, atezolizumab, shows a clinically meaningful survival benefit of atezolizumab over docetaxel in previously treated patients with non-small-cell lung cancer regardless of PD-L1 expression or histology, with a favorable safety profile compared with docetaxel.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Locally advanced or metastatic (Stage 3B, Stage 4, or recurrent) non-small cell lung cancer (NSCLC)
- •Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
- •Measurable disease, as defined by RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Known active or untreated central nervous system (CNS) metastases
- •Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- •History of autoimmune disease
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •Active hepatitis B or hepatitis C
- •Prior treatment with docetaxel
- •Prior treatment with CD137 agonists, anti CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
研究者
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