A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Were Previously Treated With First Line Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change From Baseline in Tumor Size to the End of Cycle 2
研究概览
简要总结
The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.
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
- None
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 with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
- •Measureable disease as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Must make available any existing tumor tissue from the primary biopsy
- •Participants with prior radiation may be eligible if they meet certain criteria
- •Adequate bone marrow reserve and organ functioning
- •Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period and must not be breastfeeding
- •Men must comply with a contraceptive regimen during and for 6 months after the treatment period
排除标准
- •Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Participants may be permitted to enter treatment before the 30 day waiting period in special circumstances
- •Pregnant or breastfeeding
- •Serious concomitant systemic disorders that would compromise the safety of the participant or the participant's ability to complete the study
- •Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
- •Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
- •Participants with documented central nervous system or brain metastasis at the time of study entry
- •Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2
研究组 & 干预措施
LY2181308 + Docetaxel
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
干预措施: Docetaxel (Drug)
LY2181308 + Docetaxel
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
干预措施: LY2181308 (Drug)
Docetaxel
Docetaxel: 75 milligrams/square meter (mg/m^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Change From Baseline in Tumor Size to the End of Cycle 2
时间窗: Baseline, End of Cycle 2 (1 cycle = 21 days)
The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. The log ratio of tumor size at the end of Cycle 2 to tumor size at baseline was calculated for each participant.
次要结局
- Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire(Baseline to the worsening of symptoms (up to 4.6 months))
- Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel(Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4,5,505,513,2521 hours(h);LY2181308 + Docetaxel: C1 D -1:3,4 h;D1:0,3,4,5,5.25,5.75,7,8,120,504,507,509,1008,1512,1515,1517,2016, 2520,2523,2525 h)
- Time to Documented Disease Progression(Randomization to the first date of progressive disease (up to 12.9 months))
- Percent of Participants Having a Partial Response (PR) or a Complete Response (CR)(Randomization to the first date of progressive disease (up to 12.1 months))
- Overall Survival (OS)(Randomization to date of death from any cause (up to 21.6 months))
- Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR)(Randomization to the date of first response (up to 12.1 months))
- Duration of Response(Time of response to progressive disease (PD) (approximately 8.7 months))
- Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) on Cycle 2 Day 1(Cycle 2 Day 1)
- Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel(Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4 hours(h);LY2181308 + Docetaxel: C1 D-1:3,4 h;D1:0,3,4 h)
- Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding(Randomization through long-term follow up (up to 21.6 months))
- Progression Free Survival (PFS)(Randomization to the first date of progressive disease or death from any cause (up to 12.88 months))
- Lung Cancer Symptom Scale (LCSS) Average Total Score at Cycle 2 Day 1(Cycle 2 Day 1)