A Therapeutic Trial of Afatinib in the Neoadjuvant Setting. Molecular Effects of Afatinib: A Window of Opportunity Trial In Early Stage NSCLC
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility
The primary endpoint will demonstrate feasibility of neoadjuvant treatment of BIBW 2992 in patients with early stage (IA to IIIA) NSCLC awaiting surgical resection. Feasibility will be assessed based on the ability to complete the treatment for each patient. For our feasibility endpoint we will declare the treatment "completed" if a patient completes at least 14 days of treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.
30 days post operative care
No
George Simon, MD
Principal Investigator
Medical University of South Carolina Hollings Cancer Center
United States: Food and Drug Administration
101596
NCT01480141
January 2012
August 2012
Name | Location |
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Medical University of South Carolina | Charleston, South Carolina 29425-0721 |