Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection

PRIMARY OBJECTIVES: I. To determine the biochemical response rate (\> 75% decrease in P-MAPK and/or P-AKT) with daily oral OSI-774 (erlotinib) for 14 consecutive days in patients with early stage, operable NSCLC. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerance of daily oral OSI-774 (erlotinib) as pre-operative treatment for early stage operable NSCLC. TERTIARY OBJECTIVES: I. To correlate antiproliferative (Ki-67, p27) and apoptotic (TUNEL assay) tumor responses to OSI-774 (erlotinib) with pre-therapy tumor and skin EGFR pathway functional status and post-therapy tumor and skin EGFR pathway inhibition in patients with resectable NSCLC treated preoperatively with OSI-774 (erlotinib) for 14 days. II. Assessment of functional EGFR status: HER1, HER-2, HER3, HER4, PHER1, AKT, P-AKT, MAPK-P-MAPK, STAT-3, P-STAT-3, EGFR-III by immunohistochemistry (IHC). III. Assessment of proliferative response: Ki67 and p27 by IHC. IV. Assessment of apoptotic response: TUNEL assay. V. To study the role of the gastrin-releasing factor and estrogen receptor pathways in the sensitivity and resistance of NSCLC to OSI-774 (erlotinib). VI. To identify patterns of gene and protein expression pre-therapy and post-therapy that are associated with tumor clinical, biochemical, antiproliferative, and apoptotic responses. VII. To study the antitumor activity of OSI-774 (erlotinib) in NSCLC tumors heterotransplanted in nude mice after surgical resection and to investigate the sequential molecular changes associated with tumor response to OSI-774 (erlotinib) therapy. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity. Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21). Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician. Patients are followed for 5 years after study registration.