A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib
- To define a pre-treatment tumor proteomic profile that predicts response, stable
disease, or progressive disease in patients with stage IIIB, stage IV, or recurrent
non-small cell lung cancer treated with erlotinib hydrochloride.
- To test and refine a pre-treatment serum proteomic expression pattern that predicts
response to erlotinib hydrochloride and/or carboplatin and paclitaxel after failing
treatment with erlotinib hydrochloride.
- To test and refine tumor proteomic profiles that predict response to carboplatin and
paclitaxel after failing treatment with erlotinib hydrochloride.
- To analyze individual and pattern(s) of erlotinib hydrochloride-induced genomic and
proteomic biomarker changes in relation to response or non-response to treatment.
- To correlate the efficacy and toxicity of erlotinib hydrochloride with expression of
EGFR, EGFR pathway, ErbB family, and other related biomarkers.
- To determine a set of biomarkers to be evaluated in tumor tissue or surrogate tissues
prior to treatment with erlotinib hydrochloride to enable patient selection for
- To estimate response rate and progression-free and overall survival of patients treated
with erlotinib hydrochloride as initial therapy.
- To characterize the safety profile of erlotinib hydrochloride in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily until disease progression.
At the time of disease progression, patients receive standard chemotherapy comprising
paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with
non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes
on day 1. Treatment repeats every 21 days for up to 6 courses.
Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics
After the completion of study treatment, patients are followed every 8 weeks.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pre-treatment tumor proteomic profile as a predictor of response, stable disease, or progressive disease
End of treatment date
David Carbone, M.D., Ph.D.
Vanderbilt-Ingram Cancer Center
United States: Vanderbilt University
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Emory University||Atlanta, Georgia 30322|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|