JPRN-jRCT2080222890已完成3 期
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN+PACLITAXEL WITH OR WITHOUT BEVACIZUMAB COMPARED WITH CARBOPLATIN+PACLITAXEL+BEVACIZUMAB IN CHEMOTHERAPY NAIVE PATIENTS WITH STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
CHUGAI PHARMACEUTICAL CO., LTD0 个研究点目标入组 1,202 人开始时间: 2015年6月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,202
研究概览
简要总结
The addition of atezolizumab to bevacizumab plus chemotherapy significantly improved progression-free survival and overall survival among patients with metastatic nonsquamous NSCLC, and the safety profile of ABCP was consistent with previously reported safety risks of the individual medicines.
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
- •18 years or older
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •- Histologically or cytologically confirmed, treatment-naive Stage IV non-squamous NSCLC
- •- Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
- •- Measurable disease as defined by RECIST v1.1
- •- Adequate hematologic and end organ function
排除标准
- •- Active or untreated central nervous system (CNS) metastasis
- •- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- •- 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 Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •- Positive test for Human Immunodeficiency Virus (HIV)
- •- Active hepatitis B or hepatitis C
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti PD-1, and anti-PD-L1 therapeutic antibody
- •- Severe infection within 4 weeks prior to randomization
- •- Significant history of cardiovascular diseas
研究者
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