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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,021
研究概览
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 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
研究者
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