A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 696
- 试验地点
- 203
- 主要终点
- Overall Survival as of 19 October 2015
研究概览
简要总结
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.
详细描述
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed.
Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.
The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.
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
- •Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
- •Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- •Prior therapy defined as 1 prior systemic therapy for advanced disease
- •Documented disease progression during or following most first line therapy for advanced disease
- •Adequate hematologic, hepatic, renal function
排除标准
- •Epidermal growth factor receptor (EGFR) mutations
- •Anaplastic lymphoma kinase (ALK) translocations
- •Predominantly squamous, adenosquamous or unclear histologic type
- •Active or untreated central nervous system (CNS) metastases
- •Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
- •Serious cardiac illness or medical conditions
- •Pregnant or lactating women
- •Uncontrolled intercurrent illness
研究组 & 干预措施
Ganetespib and Docetaxel
Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
干预措施: Docetaxel (Drug)
Ganetespib and Docetaxel
Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
干预措施: Ganetespib (Drug)
Docetaxel
Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival as of 19 October 2015
时间窗: up to 36 months
Overall survival (OS) was measured from the date of randomization to the date of death from any cause.
次要结局
- Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015(up to 36 months)
- Progression-free Survival (PFS) as of 19 October 2015(up to 36 months)
- Objective Response Rate (ORR) as of 19 October 2015(up to 36 months)
- Disease Control Rate (DCR) as of 19 October 2015(up to 36 months)
- Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015(up to 36 months)
- Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015(up to 36 months)
- Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015(up to 36 months)
- Participants With Treatment-Emergent Adverse Events as of 23 December 2015(up to 36 months)
- Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test(Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial)
- Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey(Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial)