NL-OMON47625已完成3 期
A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non*small-cell lung cancer - EMR100070-005 - JAVELIN Lung 100
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Merck
- 入组人数
- 3
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 99（—）
入选标准
- •Male or female subjects * 18 years, with an ECOG PS of 0 to 1 at trial entry,
- •with the availability of a formalinfixed, paraffin-embedded block containing
- •tumor tissue or 7 (preferably 10) unstained tumor slides with PD-L1+, at least
- •1 measurable tumor lesion, and with histologically confirmed metastatic or
- •recurrent NSCLC. Subjects must not have received any treatment for systemic
- •lung cancer, and have an estimated life expectancy of more than 12 weeks.
排除标准
- •Subjects whose disease harbors an activating EGFR mutation, or with
- •non-squamous cell NSCLC whose disease harbors and anaplastic lymphoma kinase
- •(ALK) rearrangement are not eligible. Other exclusion criteria include prior
- •therapy with any antibody or drug targeting T cell coregulatory proteins,
- •concurrent anticancer treatment, or immunosuppressive agents, known severe
- •hypersensitivity reactions to monoclonal antibodies (Grade * 3 NCI
- •CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or
- •more features of partially controlled asthma), and persisting toxicity related
- •to prior therapy of Grade > 1 NCI-CTCAE v 4.03. Subjects with brain metastases
- •are excluded, except those meeting the following criteria: brain metastases
- •that have been treated locally and are clinically stable for at least 2 weeks
- •prior to enrollment, subjects must be either off steroids or on a stable or
- •decreasing dose of <10mg daily prednisone (or equivalent), do not require
- •steroid maintenance therapy, and do
- •not have ongoing neurological symptoms that are related to the brain
- •localization of the disease.
- •Other protocol defined criteria could apply.
- •All potential exceptions must be discussed with the study Medical Monitor prior
- •to enrollment.
研究者
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