Trial Information

A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).

The promising activity of erlotinib as a single agent in advanced refractory NSCLC along
with its oral administration and favorable adverse event profile makes this agent an
excellent candidate to incorporate into combined modality therapy in the early stages of
lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance
therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation.
Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors
following chemotherapy and thoracic radiation therapy, the vast majority relapse within the
first year following therapy and eventually die from chemotherapy refractory disease. We
hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal
growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and
carboplatin will prolong the progression-three survival time for these patients.