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
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
- 572
- 状态
- 已完成
- 最后更新
- 2年前
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.
研究者
入排标准
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
结局指标
主要结局
未指定
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