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Spots Global Cancer Trial Database for A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)

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Trial Identification

Brief Title: A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)

Official Title: A Therapeutic Trial of Afatinib in the Neoadjuvant Setting. Molecular Effects of Afatinib: A Window of Opportunity Trial In Early Stage NSCLC

Study ID: NCT01480141

Conditions

Lung Cancer

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Medical University of South Carolina, Charleston, South Carolina, United States

Contact Details

Name: George Simon, MD

Affiliation: Medical University of South Carolina Hollings Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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