Trial Information

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC

This is a phase II, single institution trial to correlate gefitinib response and mutations
in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted
in patients with Stage I and II NSCLC who have been determined to be operable and
resectable.

Patients must have 1 or more of the following features: never smoker or smoking history of <
15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be
enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery
(depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before
their operation. For patients that demonstrate a radiographic response to gefitinib
preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the
EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years
post-surgery. Patients who do not have evidence of radiographic response or mutations in the
protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.