Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Advanced Sorafenib Erlotinib Double-blind Placebo-controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 166
Healthy volunteers: no

Brief summary:
This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.

Detailed description:
The rationale of this study is to combine two distinct kinase inhibitors to evaluate synergistic inhibition of angiogenesis and epidermal growth factor receptor (EGFR) signaling. Erlotinib is a oral tyrosine kinase inhibitor that targets EGFR. Sorafenib is a oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), platelet derived growth factor receptor beta, Raf-1, Flt-3, and C-kit. These agents also do not exhibit overlapping adverse event profiles which provided additional support for studying this combination therapy.

Arms:
arm 1: Erlotinib + Sorafenib arm 2: Erlotinib + Placebo

Interventions: intervention 1: Erlotinib + Sorafenib intervention 2: Erlotinib + Placebo
Intervention descriptions: intervention 1: Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day. intervention 2: Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.

Protocol document: