Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
3期
进行中（已停止招募）
NCT01933932
| 适应症 | Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV |
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| 分期 | 3期 |
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| 申办方 | AstraZeneca |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 510 人 |
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| 干预（药物） | Selumetinib, Docetaxel, Pegylated G-CSF |
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| 开始日期 | 2013年9月25日 |
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| 完成日期 | 2016年6月7日 |
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| 结果公布日 | 2017年8月29日 |
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摘要
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Progression-Free Survival (PFS)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI) · Months
| Selumetinib + Docetaxel | 3.9 Months |
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| Placebo + Docetaxel | 2.8 Months |
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| p-value | 0.4355 |
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| Hazard Ratio (HR) | 0.93 (95% CI 0.77–1.12) |
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