EUCTR2013-001662-42-DE进行中（未招募）1 期
A Randomized, Double-blind, Multi-center Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult subjects with histologically or cytologically confirmed stage IV NSCLC who provide a tumor sample and are planned to receive 4-6 cycles of platinum-doublet based chemotherapy
- •Radiographically evaluable disease according to modified RECIST 1.1 criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 97
排除标准
- •Known presence of epidermal growth factor receptor (EGFR) mutation
- •Known brain metastases
- •Any prior therapy (before randomization) for the treatment of NSCLC, except if for non-metastatic disease and was completed at least 6 months prior to randomization
- •Planned to receive bevacizumab
- •Subjects with sarcomatoid, carcinoid, and mesenchymal histologies
- •More than 1 year of cumulative oral bisphosphonate usage prior to randomization
- •More than 1 previous dose of IV bisphosphonate administration prior to randomization
- •Significant dental/oral disease, including prior history or current
- •evidence of osteonecrosis/ osteomyelitis of the jaw
- •Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium, or vitamin D)
研究者
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