Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
The Compassionate Use Programme will also provide additional safety information on gilotrif use.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib|
- response rate [ Time Frame: 6 months ]
|Study Start Date:||July 2011|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
50 mg with an option to reduce the dose to 40mg or 30 mg once a day Continuous daily dosing, one course consists of 28 days. Patients are eligible for repeated treatment courses in the absence of disease progression and undue toxicity.
Other Name: Afatinib