NCT01362296

An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer

A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

Conditions

• Lung Cancer, Non-Small Cell

Interventions

Type	Name	Description
DRUG	GSK1120212	Oral once daily
DRUG	docetaxel	IV once every 3 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-09-01
• Completion: 2013-09-01
• First posted: 2011-05-30
• Last updated: 2014-07-11
• Results posted: 2014-05-26

Locations

60 sites across 8 countries: United States, France, Greece, Hungary, Italy, Netherlands, South Korea, Spain