ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- Response Rate (Centrally Assessed)
研究概览
简要总结
The objective of the study is to investigate the efficacy and safety 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
- Non Randomized
- 干预模型
- Parallel
- 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 for squamous non-small-cell lung cancer (NSCLC)
In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.
干预措施: ONO-4538 (Drug)
ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC)
In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Response Rate (Centrally Assessed)
时间窗: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Response rate (%) = (Number of subjects whose confirmed best overall response was complete response (CR) or partial response (PR) / Total number of FAS)\*100. 95% Confidence interval (CI) was calculated by Wilson method.
次要结局
- Response Rate (Investigator-assessed)(Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.)
- Overall Survival(Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.)
- Progression Free Survival (Centrally Assessed)(Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.)
- Duration of Response (Centrally Assessed)(Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.)