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A081105 Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Protocol Number:
Phase III
Patrick Forde
Johns Hopkins Kimmel Cancer Center in Baltimore
Johns Hopkins Bayview Medical Center
Sibley Memorial Hospital
The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug) if the tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). We are trying to find out if this mutation could help us make decisions about which type of treatment is best for people with your type of cancer.
Generally healthy adults with early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation may be eligible.
First, you will be asked to consent to submit part of your tumor, which was already removed during surgery, to the study for testing of the EGFR gene. If you have the EGFR mutation, you will then sign consent for this study and undergo screening tests. If you are eligible, you will take a pill every day as long as you are receiving a benefit or for up to 2 years. The pill will either be erlotinib or a placebo (inactive substance). You and the study staff will not know what you are taking. YOu will be asked to come to clinic to see the doctor and have blood tests done every 21 days and CT scans done on a regular basis in order to monitor you while taking the study drug. Then, we would like to keep in touch with you about your disease status for up to 5 years.
Last Update
08/11/2020 05:02 AM