A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)
Status:
Withdrawn
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
This study is for patients that have Non-Small Cell Lung Cancer (NSCLC) and he or she will
have surgery to remove the tumor. The main purpose of this study is to study how safe and
suitable treatment with Afatinib is in participants before surgery to remove the tumor.
Another goal of the study is to see if treatment with Afatinib affects the growth and
activity of the tumor. Afatinib has not been approved for use by the FDA (Food and Drug
Administration) and is experimental.
In some persons, the growth of cancer cells is thought to be stimulated by Epidermal Growth
Factor (EGF). This is a protein found in the body which binds to the cell wall to sites
called receptors and stimulates cell growth. Some cells have too many receptors and
uncontrolled growth and because of this, develop into a cancer tumor. There are several other
cancer drugs that bind to these receptors to slow or stop cancer growth such as Gefitinib and
erlotinib which are FDA approved and used for the treatment of NSCLC.
The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may
be a candidate for the treatment of NSCLC and a variety of early stage cancers. Participants
in this study will take Afatinib by mouth, in pill form, for at least 14 days before having
their scheduled surgery to remove their cancer tumor. Participants will be observed for side
effects and followed for 30 days after surgery to assess the results after surgery.