NCT02582125已完成2 期
ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
研究概览
简要总结
The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 20 years of age
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
- •Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)
排除标准
- •Current or prior severe hypersensitivity to another antibody product
- •Multiple primary cancers
研究组 & 干预措施
ONO-4538
Experimental
ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
时间窗: Approximately 6 months
次要结局
- Response rate (centrally assessed)(Approximately 6 months)
- Response rate (study site assessment by investigator)(Approximately 6 months)
- Overall survival(Approximately 1 year)
研究者
研究点 (8)
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