NCT06542731进行中（未招募）1 期
Phase 1 Study of ONO-4578 Given as Combinations of ONO-4578, ONO-4538, Docetaxel and Ramucirumab in Subjects With Metastatic Non-small Cell Lung Cancer Who Have Had Disease Progression During or After One Prior First-line Anti-PD-(L) 1 Antibody and Platinum-based Chemotherapy for Advanced/Metastatic Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 13
- 主要终点
- Dose-limiting toxicities（DLT）
研究概览
简要总结
This study is PhaseⅠstudy to evaluate the tolerability and safety of ONO-4578 and ONO-4538 in combination with standard-of-care docetaxel and ramucirumab as second-line therapy in patients with advanced or recurrent NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug
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
- •Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer
- •Life expectancy of at least 3 months
- •Patients with ECOG performance status 0 or 1
排除标准
- •Patients with severe complication
- •Patients with multiple primary cancers
研究组 & 干预措施
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
Experimental
干预措施: ONO-4578 (Drug)
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
Experimental
干预措施: ONO-4538 (Drug)
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
Experimental
干预措施: Docetaxel (Drug)
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
Experimental
干预措施: Ramucirumab (Drug)
结局指标
主要结局
Dose-limiting toxicities（DLT）
时间窗: 21 days
Adverse event(AE)
时间窗: Up to 28 days after the last dose
次要结局
- Overall survival (OS)(Up to 2 years)
- Pharmacokinetics（Plasma concentration of ONO-4578）(Up to 28 days after the last dose)
- Pharmacokinetics（serum concentration of ONO-4538）(Up to 28 days after the last dose)
- Overall response rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Time to response (TTR)(Up to 2 years)
- Best overall response (BOR)(Up to 2 years)
- Percentage of change in the sum of tumor diameters of target lesions(Up to 2 years)
- Maximum percentage of change in the sum of tumor diameters of target lesions(Up to 2 years)
- Changes in tumor markers（CYFRA,CEA,SLX）(Up to 2 years)
研究者
研究点 (13)
Loading locations...
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