A Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the Informed Consent Form;
- •Male or female ≥ 18 and≤75 years of age;
- •Life expectancy ≥ 12 weeks;
- •Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging;
- •At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression.
排除标准
- •Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy;
- •Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug;
- •Received any investigational agent within 4 weeks prior to the first dose of study drug;
- •Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
- •Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
- •Pregnant or breastfeeding woman.
研究组 & 干预措施
IBI318 in combination with paclitaxel
干预措施: paclitaxel (Drug)
IBI318 in combination with paclitaxel
干预措施: IBI318 (Drug)
结局指标
主要结局
Adverse events
时间窗: 3 months
The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity.
Objective remission rate
时间窗: 12 months
Proportion of subjects with complete response (CR) or partial response (PR).
次要结局
- Continuous remission time (DOR)(12 months)
- Disease Control Rate (DCR)(12 months)
- Time to response (TTR)(12 months)
- Progression-free survival (PFS)(12 months)
- Overall survival (OS)(12 months)