Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:August 2004
End Date:February 2016

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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.

Inclusion Criteria:

Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and
who fulfill the following eligibility criteria will be considered eligible for this study.

- Patient must have previously received treatment with small molecule kinase inhibitors
targeting at least, in part, EGFR patients may have received other treatments since
treatment with small molecule kinase inhibitors including radiation or chemotherapy)

- Development of disease progression while actively receiving tyrosine kinase inhibitor

- Signed informed consent

Exclusion Criteria:
We found this trial at
5
sites
1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Rockville Centre, NY
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Basking Ridge, New Jersey
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from
Basking Ridge, NJ
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from
Commack, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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from
Sleepy Hollow, NY
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