A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Number of Months of Progression-free Survival (PFS)
Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.
From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA225-099
NCT00112294
December 2004
August 2008
Name | Location |
---|---|
Local Institution | Chicago, Illinois |
Local Institution | Indianapolis, Indiana |
Local Institution | Baltimore, Maryland |
Local Institution | Bronx, New York |
Local Institution | Cincinnati, Ohio |
Local Institution | Vancouver, Washington |
Local Institution | Green Bay, Wisconsin |
Local Institution | Birmingham, Alabama |
Local Institution | Phoenix, Arizona |
Local Institution | Corona, California |
Local Institution | Aurora, Colorado |
Local Institution | Hamden, Connecticut |
Local Institution | Washington, District of Columbia |
Local Institution | Fort Lauderdale, Florida |
Local Institution | Wichita, Kansas |
Local Institution | Springfield, Massachusetts |
Local Institution | Duluth, Minnesota |
Local Institution | New Brunswick, New Jersey |
Local Institution | Wilmington, North Carolina |
Local Institution | Oklahoma City, Oklahoma |
Local Institution | Duncansville, Pennsylvania |
Local Institution | North Charleston, South Carolina |
Local Institution | Austin, Texas |
Local Institution | Arlington, Virginia |
Local Institution | Rome, Georgia |
Local Institution | Bismarck, North Dakota |
Local Institution | Providence, Rhode Island |
Local Institution | Chattanooga, Tennessee |
Local Institution | Little Rock, Arkansas |
Local Institution | Jackson, Mississippi |
Local Institution | Columbia, Missouri |
Local Institution | Morgantown, West Virginia |
Local Institution | Louisville, Kentucky |
Local Institution | Detroit, Michigan |
Local Institution | Honolulu, Hawaii |
Local Institution | Lebanon, New Hampshire |
Local Institution | Anchorage, Alaska |