Stage IIIB Non-Small Cell Lung Cancer Clinical Trial
Official title:
EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)
This phase II trial studies how well erlotinib hydrochloride works before surgery in treating patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To estimate the rate of mediastinal nodal clearance and complete pathological response
after neoadjuvant erlotinib (erlotinib hydrochloride) in patients with epidermal growth
factor receptor (EGFR) mutated stage III non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To determine the progression free survival in patient population of EGFR mutated stage III
NSCLC patients who are treated with neoadjuvant erlotinib therapy.
II. To determine the overall survival. III. To estimate the overall response rate from
neoadjuvant erlotinib. IV. To estimate the surgical resection rate. V. To evaluate the safety
of neoadjuvant erlotinib.
TERTIARY OBJECTIVES:
I. To determine several molecular and cellular biomarkers in the tumors, the skin and the
serum that are predictive of the efficacy of neoadjuvant erlotinib.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for 2 months and then
undergo thoracotomy.
After completion of study treatment, patients are followed up at 30 days, every 3 months for
1 year, and then every 6 months for 5 years.
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