CTIS2022-502031-20-00招募中1 期
A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in combination with Atezolizumab plus Pemetrexed and Carboplatin/Cisplatin versus Pembrolizumab plus Pemetrexed and Carboplatin/Cisplatin in Patients with previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer - BO42592
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, 2. Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy, 3. No prior systemic treatment for metastatic non-squamous NSCLC, 4. Known tumor PD-L1 status, 5. Measurable disease, as defined by RECIST v1.1, 6.Negative HIV test and Serology test negative for active hepatitis B virus and active hepatitis C virus at screening
排除标准
- •1. Patients with NSCLC which harbors a mutation in the EGFR gene or an ALK fusion oncogene, 2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases, 3. Active or history of autoimmune disease or immune deficiency, 4. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, 5. History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death, 6. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4 (CTLA4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
研究者
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