A Phase II Study of AZD1775 Plus Pemetrexed and Carboplatin Followed by a Randomised Comparison of Pemetrexed and Carboplatin With or Without AZD1775 in Patients With Previously Untreated Stage IV Non-Squamous Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.
详细描述
This is a randomised, phase II trial comparing AZD1775 plus pemetrexed and carboplatin followed by maintenance AZD1775 and pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed in patients with previously untreated metastatic non-squamous NSCLC with TP53 mutations. The primary endpoint of the trial is assessment of progression-free survival (PFS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AZD1775 + carboplatin + pemetrexed
Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
干预措施: AZD1775 (Drug)
AZD1775 + carboplatin + pemetrexed
Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
干预措施: pemetrexed (Drug)
AZD1775 + carboplatin + pemetrexed
Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
干预措施: carboplatin (Drug)
Placebo + carboplatin + pemetrexed
Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
干预措施: AZD1775 Matching Placebo (Drug)
Placebo + carboplatin + pemetrexed
Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
干预措施: pemetrexed (Drug)
Placebo + carboplatin + pemetrexed
Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
干预措施: carboplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 6 months
Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
次要结局
- Assess the Objective Response Rates in Each Arm(Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days))
- Assess the Disease Control Rate in Each Treatment Arm(Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days))
- Assess the Duration of Response in Each Treatment Arm(Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days))
- Assess Overall Survival in Each Treatment Arm(Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days))