JPRN-jRCT2080223142已完成3 期
A PHASE III,OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN+PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN+PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 578
研究概览
简要总结
Atezolizumab plus pemetrexed and platinum chemotherapy offered longer PFS and a non-significant but numerically better OS compared with pemetrexed plus platinum- based chemotherapy in the first-line treatment of patients with non-squamous NSCLC, with a manageable safety profile.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •-Histologically or cytologically confirmed, treatment-naieve Stage IV non-squamous NSCLC
- •-No prior treatment for Stage IV non-squamous NSCLC.
- •-Measurable disease as defined by RECIST v1.1
- •-Adequate hematologic and end organ function
排除标准
- •-Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene
- •-Active or untreated central nervous system (CNS) metastasis
- •-Malignancies other than NSCLC within 5 years prior to randomization
- •-Known tumor PD-L1 expression status from other clinical studies
- •-History of certain autoimmune disease
- •-History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- •-History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
- •-Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •-Severe infection within 4 weeks prior to randomization
- •-Significant history of cardiovascular disease
研究者
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