A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
Chemotherapy and surgery in combination represents the standard of care for patients with
resectable stage IB-IIIA NSCLC. However, the 5-year survival continues to be disappointing
despite this standard of care. This study incorporates targeted therapy with an epidermal
growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) as part of a multimodality
strategy for stage IB-IIIA resectable NSCLC tumors with a known EGFR activating mutation.
The rationale for including only patients with EGFR mutations is based on recent data that
reported that patients with advanced NSCLC whose tumor harbor EGFR activating mutations had
an objective response rate of 71% with gefitinib compared with a 1% objective response rate
in patients with EGFR wild-type tumors.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the pathologic complete response rate for patients with stage IB-IIIA NSCLC with tumors that harbor an EGFR mutation treated with neoadjuvant chemotherapy + erlotinib
Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|