Conditions: Lung Cancer, Non-Small Cell
Keywords: NRAS docetaxel NSCLC GSK1120212 MEK inhibitor targeted therapy KRAS BRAF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 134
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Oral once daily arm 2: IV once every 3 weeks

Interventions: intervention 1: GSK1120212 intervention 2: docetaxel
Intervention descriptions: intervention 1: Oral once daily intervention 2: IV once every 3 weeks

Protocol document: