JPRN-jRCT2080222849已完成3 期
A PHASE III, OPEN LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH A PLATINUM AGENT (CISPLATIN OR CARBOPLATIN) IN COMBINATION WITH EITHER PEMETREXED OR GEMCITABINE FOR PD-L1-SELECTED, CHEMOTHERAPY-NAIVE PATIENTS WITH STAGE IV NON-SQUAMOUS OR SQUAMOUS NON-SMALL CELL LUNG CANCER
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 572
研究概览
简要总结
Atezolizumab monotherapy resulted in longer overall survival than platinum-based combination chemotherapy among patients with previously untreated metastatic NSCLC with high expression of PD-L1. Toxic effects were consistent with those that have been reported previously.
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
- •Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC without any prior treatment
- •-Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •-Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- •-Adequate hematologic and end-organ function
排除标准
- •-Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
- •-Active or untreated central nervous system (CNS) metastases as determined by computed tomorgaphy (CT) or magnetic resonance imaging (MRI) evaluation
- •-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 PD1, and anti-PD-L1 therapeutic antibody
- •-Severe infection within 4 weeks prior to randomization
- •-Significant history of cardiovascular disease
研究者
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