NCT00099541已完成4 期
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 201
- 主要终点
- Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
研究概览
简要总结
This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age greater than or equal to 18 years
- •Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
- •Unresectable Stage IIIB with pleural effusion or stage IV NSCLC
- •ECOG performance status of 0 or 1
排除标准
- •Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)
- •Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
- •Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
- •Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
- •Abnormal renal function or creatinine clearance
- •Unstable brain metastasis
- •Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
- •Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
结局指标
主要结局
Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
Group 2: Observational
次要结局
- Patients with an SRE will be evaluated for:
- Time from stage IIIB/IV NSCLC diagnosis to progression to bone
- Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
- The effect of serum NTX levels on the development of skeletal events (SREs), and
- Overall survival
- Group 2: Obervational
研究者
研究点 (201)
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