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
Phase 3
Active, not recruiting
NCT01933932
| Condition | Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 510 participants |
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| Interventions | Selumetinib, Docetaxel, Pegylated G-CSF |
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| Start date | Sep 25, 2013 |
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| Completion date | Jun 7, 2016 |
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| Results posted | Aug 29, 2017 |
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Summary
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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Open in BENITIONS
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