Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of participants with advanced stage non-small cell lung cancer.
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
- Double (Participant, Investigator)
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
- •participants or their legal representative must have signed an informed consent document for clinical research
- •have laboratory confirmed diagnosis of advanced, nonsquamous cell non-small cell lung cancer (NSCLC) (Stage IIIB or IV disease) which is not curable
- •have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
- •have measurable disease
- •have adequate organ function and estimated life expectancy of 12 weeks
排除标准
- •have known central nervous system (CNS) disease; major surgery within 28 days; minor surgery within 7 days; serious concomitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
- •have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
- •have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
- •are pregnant or breast-feeding
- •are unable to swallow tablets
研究组 & 干预措施
A
Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
干预措施: enzastaurin (Drug)
A
Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
干预措施: pemetrexed (Drug)
A
Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
干预措施: carboplatin (Drug)
A
Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
干预措施: bevacizumab (Drug)
B
Pemetrexed + Carboplatin + Bevacizumab + Placebo
干预措施: pemetrexed (Drug)
B
Pemetrexed + Carboplatin + Bevacizumab + Placebo
干预措施: carboplatin (Drug)
B
Pemetrexed + Carboplatin + Bevacizumab + Placebo
干预措施: bevacizumab (Drug)
B
Pemetrexed + Carboplatin + Bevacizumab + Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Randomization to measured PD or death from any cause up to 12.2 months
PFS was defined as the time from date of randomization to the first observation of progressive disease (PD) or death due to any cause. For participants not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to objective disease progression or death, PFS was censored at the date of the last objective progression-free assessment prior to the initiation of post-discontinuation anticancer therapy.
次要结局
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)(Randomization to measured progressive disease or death from any cause up to 12.2 months)
- Overall Survival (OS)(Randomization to date of death up to 14.3 months)
- Duration of Response (DoR)(Time of response to disease progression or death from any cause up to 12.2 months)
- Time to Progressive Disease (TTPD)(Randomization to measured PD or death from any cause up to 12.2 months)
- Pharmacology Toxicity and Adverse Events (AEs)(Randomization up to 14.3 months and 30-day follow-up)