Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 主要终点
- Overall Survival
研究概览
简要总结
Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.
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
- •Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung
- •No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies or investigational drugs
排除标准
- •Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg, small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or cytological diagnosis of primary lung cancer
- •Adenocarcinoma arising from primary sites other than the lung
- •Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging System 7th edition)
- •Patients with unstable CNS mets within 21 days before randomization
研究组 & 干预措施
Placebo
Placebo in combination with cisplatin and either paclitaxel or docetaxel
干预措施: Placebo in combination with cisplatin and docetaxel or paclitaxel (Drug)
Tavocept (BNP7787)
Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel
干预措施: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: throughout study
次要结局
- Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline(throughout the study)
- Incidence of NCI-CTCAE grade 2,3, or 4 anemia(throughout the study)
- Proportion of patients having no impact of chemotherapy-induced emesis on daily life(throughout the study)
- Progression Free Survival(Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment)