Lung Cancer Clinical Trial
Official title:
A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
The purpose of this study is to try to improve the odds that your cancer may be cured.
Pemetrexed and cisplatin are traditional chemotherapy drugs that have been shown to help some
patients with non-small cell lung cancer. Many different types of cancer cells, including
your type of lung cancer, have a protein on their surface called the epidermal growth factor
receptor (EGFR). Stimulation of these receptors can result in growth of cancer cells and
progression of cancer. In addition, your cancer has an EGFR mutation (a specific abnormality
in the genetic code for EGFR). Erlotinib (TarcevaTM) is a newer drug which has shown benefit
for patients with lung cancers that contain an EGFR mutation. Erlotinib works by blocking
this receptor and depriving the cancer cells of this message to grow and multiply. In this
research study, we plan to combine erlotinib with traditional chemotherapy drugs to see if
the combination works better than chemotherapy alone.
The main purpose of this research is to find out the good and bad effects that the
combination of these 3 drugs (pemetrexed, cisplatin and erlotinib) has when given to patients
with early stage non-small cell lung cancer before surgery. A secondary purpose is to find
out the good and bad effects that occur when erlotinib is given to patients after surgery for
2 years.
Chemotherapy and surgery in combination represents the standard of care for patients with resectable stage IB-IIIA NSCLC. However, the 5-year survival continues to be disappointing despite this standard of care. This study incorporates targeted therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) as part of a multimodality strategy for stage IB-IIIA resectable NSCLC tumors with a known EGFR activating mutation. The rationale for including only patients with EGFR mutations is based on recent data that reported that patients with advanced NSCLC whose tumor harbor EGFR activating mutations had an objective response rate of 71% with gefitinib compared with a 1% objective response rate in patients with EGFR wild-type tumors. ;
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