Clinical Trial: TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional



Official Title: A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Brief Summary:

The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control Non-Small Cell Lung Cancer (NSCLC). The safety of this combination treatment will also be studied.

Researchers will also test the tissue from your earlier biopsy to measure the levels of epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any link between various forms of EGFR and your response to treatment with erlotinib.

Primary Objective:

Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. Safety is measured by the rate of grade 3 or worse nonhematological toxicities occurring prior to the beginning of consolidation therapy (including all toxicities attributed to chemoradiation occurring within 90 days of the start of radiation therapy); compliance is defined as the completion of the treatment regimen with no more than minor variations.

Secondary Objectives:

  1. Investigate associations between EGFR expression and toxicity, response, overall survival, and progression
  2. Estimate overall survival of patients on the study regimen (one and two year rates, median survival).
  3. Estimate the time to disease progression of patients on the study regimen (one and two year rates)
  4. Estimate the treatment response rate of patients on the study regimen (complete and partial response rates)