SELECT: A Phase II Trial of Adjuvant Erlotinib in Patients With Resected Epidermal Growth Factor Receptor-Mutant Non-Small-Cell Lung Cancer.

ABSTRACT:

Purpose

Given the pivotal role of epidermal growth factor receptor (EGFR) inhibitors in advanced EGFR-mutant non-small-cell lung cancer (NSCLC), we tested adjuvant erlotinib in patients with EGFR-mutant early-stage NSCLC.

Materials and methods

In this open-label phase II trial, patients with resected stage IA to IIIA (7^th edition of the American Joint Committee on Cancer staging system) EGFR-mutant NSCLC were treated with erlotinib 150 mg per day for 2 years after standard adjuvant chemotherapy with or without radiotherapy. The study was designed for 100 patients and powered to demonstrate a primary end point of 2-year disease-free survival (DFS) greater than 85%, improving on historic data of 76%.

Results

Patients (N = 100) were enrolled at seven sites fro

SUBMITTER: Pennell NA 

PROVIDER: S-EPMC6524649 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature