The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
Local Institution
Little Rock, Arkansas, United States
Local Institution
Long Beach, California, United States
Local Institution
Boynton Beach, Florida, United States
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab
Time frame: Every 6 weeks
Tumor response
Time frame: Every 6 weeks
Disease control
Time frame: Every 6 weeks
Overall survival (OS)
Time frame: Every 4 months after subject off-treatment until 1 year after LPLT
Duration of Response
Time frame: Every 6 weeks
Safety & exploratory biomarker analysis
Time frame: Every 3 weeks
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Local Institution
Chicago, Illinois, United States
Local Institution
Skokie, Illinois, United States
Local Institution
Wichita, Kansas, United States
Local Institution
Louisville, Kentucky, United States
Local Institution
Mount Sterling, Kentucky, United States
Local Institution
Annapolis, Maryland, United States
Local Institution
Kalamazoo, Michigan, United States
...and 4 more locations