Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
A Prospective Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer
The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.
The goal of this protocol is to determine mechanisms of resistance to epidermal growth
factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A
number of trials have shown small molecule kinase inhibitors to be active agents in the
treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but
infrequent responses. Mutations in the epidermal growth factor receptor have been shown to
correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most
patients who have initial responses to EGFR-TKI eventually progress. The mechanism of
acquired clinical resistance to these inhibitors in patients incompletely understood.
This is a protocol to study clinical characteristics and biopsy tissue of patients with
non-small cell lung cancer who have had previous clinical response to small molecule kinase
inhibitors and subsequently experience progression of disease. The tissues and other
specimens will be used to carry out laboratory studies to explore the molecular basis of
sensitivity and resistance to small molecule kinase inhibitors.
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Observational Model: Case-Only, Time Perspective: Prospective