A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 185
- 试验地点
- 33
- 主要终点
- BICR-assessed progression-free survival (PFS)
研究概览
简要总结
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged 18-75 years
- •Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC)
- •Ongoing clinical benefit (partial response [PR], or complete response [CR] per RECIST version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Subjects must have adequate bone marrow, renal and hepatic function
排除标准
- •Subjects with Central Nervous System (CNS) metastases
- •Subjects receiving consolidative chest radiation after last dose of first-line chemotherapy.
- •Subjects with pleural effusions that cannot be controlled with appropriate interventions.
- •All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
研究组 & 干预措施
ZL-2306(nirapairb)
干预措施: ZL-2306(nirapairb) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
BICR-assessed progression-free survival (PFS)
时间窗: Approximately 14 months since the first subject enrolled
The time assessed by the Blinded Independent Central Review (BICR) from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Overall survival (OS)
时间窗: Approximately 48 months since first subject enrolled
The time from randomization to death due to any cause.
次要结局
- Investigator-assessed PFS(Approximately 14 months since the first subject enrolled)