A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens
- To assess the response rate of sorafenib tosylate in combination with erlotinib
hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1
or 2 prior chemotherapy regimens.
- To assess the response duration in patients treated with this regimen.
- To assess the disease control rate in patients treated with this regimen.
- To assess the progression-free survival of patients treated with this regimen.
- To assess the overall survival of patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
- To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of
EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway
(phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3).
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice
daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or
Tissue samples are analyzed at the nucleic acid level for EGFR mutation (exon 18-21) and
K-ras mutation (exon 2), DNA mutations via PCR, presence of EGFR protein by IHC, and
downstream effectors of EGFR activation by IHC.
After completion of study therapy, patients are followed periodically.
Masking: Open Label, Primary Purpose: Treatment
Tumor response based on RECIST criteria
Joo-Hang Kim, MD