Sorafenib Treatment in Non-Small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor
This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation between clinical outcomes and biochemical modulation of signal transduction pathways.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sorafenib (BAY 43-9006®) in Patients With Relapsed Advanced Non-Small Cell Lung Cancer(NSCLC) After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)Treatment|
- Disease control rate (CR+PR+SD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- time-to-progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- safety profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Patients with stage IIIB/IV NSCLC who failed EGFR-TKI therapy will receive oral sorafenib 400 mg twice daily until disease progression or unacceptable toxicity.
Drug: sorafenib (Nexavar)
oral sorafenib 400 mg, twice daily, until disease progression or unacceptable toxicity
Sorafenib, an oral multi-kinase inhibitor, targets the Raf/MEK/ERK pathway at the level of Raf kinase and VEGF receptor tyrosine kinases, and has shown efficacy against NSCLC in Phase I/II trials. Because the targets of sorafenib are different from that of EGFR-TKI, it is reasonable for sorafenib to treat relapsed advanced NSCLC after failure of EGFR-TKI treatment.