A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
It is widely accepted that patients with locally advanced non-small cell lung cancer would
have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However
what should be the standard treatment option is still unclear.
Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine
kinase and its anti-neoplastic effect is approved especially women, patients with
adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR
mutation, its efficacy is known to be enhanced.
So we expect that in those population, patients with locally advanced, N2 positive,
erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and
convenience as neoadjuvant therapy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Korea: Food and Drug Administration