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
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- on-Small Cell Lung Cancer
- 发起方
- CHUGAI PHARMACEUTICAL CO., LTD
- 入组人数
- 1202
- 状态
- 已完成
- 最后更新
- 2年前
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.
研究者
入排标准
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
结局指标
主要结局
未指定
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