JPRN-jRCT2080222847
已完成
3 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL OR ATEZOLIZUMAB IN COMBINATION WITH CARBOPLATIN + NAB PACLITAXEL VERSUS CARBOPLATIN + NAB-PACLITAXEL IN CHEMOTHERAPY NAIVE PATIENTS WITH STAGE IV 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
- 1021
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Addition of atezolizumab to Carboplatin and nab-paclitaxel provides overall survival and progression-free survival benefit in patients with metastatic squamous NSCLC whose tumors have high PD-L1 expression. The safety profile in this trial was consistent with the known safety profile of each individual treatment, and no new safety signals were observed.
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 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 disease
结局指标
主要结局
未指定
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