A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
- •Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
- •Patients must have received primary treatment for their disease and had no progression
排除标准
- •Diagnosed with NSCLC longer than 6 months ago
- •Treatment with other bisphosphonates in past 12 months
- •Presence of metastases
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Zoledronic acid
Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
干预措施: Zoledronic acid 4 mg (Drug)
Control
No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
干预措施: Zoledronic acid 4 mg (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Up to 24 months
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Kaplan-Meier Estimates for Progression-free Survival
时间窗: Months 6, 12, 18, and 24
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Percentage of Participants With Progression-Free Survival Events
时间窗: Up to 24 months
Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
次要结局
- Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months(Months 6, 12, 18 and 24)
- Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases(Months 6, 12, 18, and 24)
- Kaplan-Meier Estimates for Overall Survival(Months 6, 12, 18, and 24)
- Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry(Months 12 and 24)
- Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)(Months 6,12, 18, and 24)