A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 197
- 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 evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Small Cell Lung Cancer disease
- •Clinical stage IV or recurrent disease
- •One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy
- •For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization
- •For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1
- •Adequate organ function
- •Estimated life expectancy of at least 3 months.
排除标准
- •Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment
- •Receiving concurrent treatment with other anticancer therapy
- •Central nervous system disease other than stable and treated brain metastasis
- •Has major blood vessel invasion or encasement by cancer
- •Has intratumor cavitation
- •Has a history of uncontrolled thrombotic disorder
- •Is receiving therapeutic anticoagulation with drugs
- •Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs
- •Has a history of hemoptysis within 2 months prior to randomization
- •Has clinically relevant congestive heart failure
- •Has experienced any arterial thromboembolic event
- •Has uncontrolled arterial hypertension
- •Has had a serious or nonhealing wound or, ulcer
- •Has significant existing conditions
研究组 & 干预措施
Ramucirumab plus Docetaxel
Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
干预措施: Ramucirumab (Drug)
Ramucirumab plus Docetaxel
Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
干预措施: Docetaxel (Drug)
Placebo plus Docetaxel
Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
干预措施: Placebo (Drug)
Placebo plus Docetaxel
Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)
PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
次要结局
- Change From Baseline in Lung Cancer Symptom Scale (LCSS)(Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks))
- Overall Survival (OS)(Baseline to Death from Any Cause (Up to 28 Months))
- Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)](Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks))
- Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)](Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks))
- Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score(Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks))