A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
Lung cancer remains the most common cause of cancer-related death in the world.
Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of
cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at
diagnosis. However, even patients with resectable disease have poor survival. The need to
improve survival rates in these patients prompted research exploring the role of systemic
therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative
chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in
patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally
administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The
presence of somatic mutations in the kinase domain of EGFR strongly correlates with
increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase
III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC
significantly improved response rate and progression-free survival (PFS) compared to
platinum-based chemotherapy. These findings prompted this phase II trial of preoperative
Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
every 8 week
Ji-Youn Han, M.D. PhD.
National Cancer Center
South Korea: Korea Food and Drug Administration (KFDA)