Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Advanced Erlotinib Sorafenib Progressing on erlotinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief summary:
This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Detailed description:

Arms:
arm 1: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth arm 2: Sorafenib 400 mg twice daily by mouth.

Interventions: intervention 1: Sorafenib intervention 2: Erlotinib
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs. intervention 2: Erlotinib 150 mg once daily by mouth

Protocol document: