NCT00609804

Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	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.
DRUG	Erlotinib	Erlotinib 150 mg once daily by mouth

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-05-01
• Completion: 2014-11-01
• First posted: 2008-02-07
• Last updated: 2016-04-08
• Results posted: 2015-06-02

Locations

16 sites across 1 country: United States