Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
NCT ID: NCT00596830
Last Updated: 2014-01-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
681 participants
INTERVENTIONAL
2008-04-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
CP-751,871 (Figitumumab)
CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
B
Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
Interventions
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CP-751,871 (Figitumumab)
CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
Eligibility Criteria
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Inclusion Criteria
* Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
* No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
* Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
* ECOG performance status (PS) 0 or 1.
Exclusion Criteria
* Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
* Patients with other active cancer types are not permitted.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Florence, Alabama, United States
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Huntsville, Alabama, United States
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Muscle Shoals, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Lone Tree, Colorado, United States
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Longmont, Colorado, United States
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Parker, Colorado, United States
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Thornton, Colorado, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
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Hudson, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Lake City, Florida, United States
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Miramar Beach, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Pensacola, Florida, United States
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Port Saint Lucie, Florida, United States
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Spring Hill, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Cumming, Georgia, United States
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Decatur, Georgia, United States
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Duluth, Georgia, United States
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Lake Spivey, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Snellville, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Arlington Heights, Illinois, United States
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Aurora, Illinois, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Galesburg, Illinois, United States
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Winfield, Illinois, United States
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Yorkville, Illinois, United States
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Avon, Indiana, United States
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Beech Grove, Indiana, United States
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Hobart, Indiana, United States
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Hobart, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Mooresville, Indiana, United States
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Mooresville, Indiana, United States
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Munster, Indiana, United States
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Cedar Rapids, Iowa, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Shawnee Mission, Kansas, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Lawrence, Massachusetts, United States
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Quincy, Massachusetts, United States
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Stoneham, Massachusetts, United States
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Weymouth, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Farmington Hills, Michigan, United States
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Saint Joseph, Michigan, United States
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Saint Louis Park, Minnesota, United States
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Columbus, Mississippi, United States
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Corinth, Mississippi, United States
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Oxford, Mississippi, United States
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Southaven, Mississippi, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Lee's Summit, Missouri, United States
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Lincoln, Nebraska, United States
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Lincoln, Nebraska, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Manchester, New Hampshire, United States
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Lake Success, New York, United States
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Manhasset, New York, United States
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New Hyde Park, New York, United States
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Oneida, New York, United States
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Oswego, New York, United States
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Syracuse, New York, United States
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Syracuse, New York, United States
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Burlington, North Carolina, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Dover, Ohio, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Clairton, Pennsylvania, United States
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Greensburg, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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McKeesport, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Radnor, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Columbia, South Carolina, United States
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Sumter, South Carolina, United States
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Bartlett, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Maryville, Tennessee, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Sam Houston, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Longview, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Tyler, Texas, United States
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Bountiful, Utah, United States
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Layton, Utah, United States
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Murray, Utah, United States
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Provo, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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West Valley City, Utah, United States
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Arlington, Virginia, United States
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Christiansburg, Virginia, United States
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Fairfax, Virginia, United States
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Gainesville, Virginia, United States
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Leesburg, Virginia, United States
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Roanoke, Virginia, United States
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Salem, Virginia, United States
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Winchester, Virginia, United States
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Woodbridge, Virginia, United States
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Wytheville, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Spokane Valley, Washington, United States
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Albury, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Geelong, Victoria, Australia
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Wodonga, Victoria, Australia
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Linz, , Austria
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Vienna, , Austria
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Rio de Janeiro, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Higienópolis, Sao Paulo/ Brazil, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sofia, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Edmonton, Alberta, Canada
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Lévis, Quebec, Canada
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Nová Ves pod Pleší, , Czechia
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Prague, , Czechia
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Pribram I, , Czechia
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Pribram V, , Czechia
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Helsinki, , Finland
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Pori, , Finland
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Caen, , France
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Caen, , France
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Clermond-Ferrand Cedex 01, , France
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Dijon, , France
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Lyon, , France
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Nantes, , France
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Rennes, , France
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Saint Pierre La Réunion Cedex, , France
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Saint-Herblain, , France
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Großhansdorf, , Germany
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Karlsruhe, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Oldenburg, , Germany
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Thessaloniki, Pylaia, Greece
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Kowloon, , Hong Kong
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Shatin, New Territories, , Hong Kong
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Tuenmen, , Hong Kong
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Budapest, , Hungary
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Deszk, , Hungary
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Székesfehérvár, , Hungary
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Szombathely, , Hungary
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Törökbálint, , Hungary
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Navrangpura / Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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New Delhi, New Delhi, India
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Genova, , Italy
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Orbassano (TO), , Italy
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Padua, , Italy
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Roma, , Italy
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Kashiwa, Chiba, Japan
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Matsuyama, Ehime, Japan
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Gifu, Gifu, Japan
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Sapporo, Hokkaido, Japan
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Akashi, Hyōgo, Japan
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Yokohama, Kanagawa, Japan
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Osaka, Osaka, Japan
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Osakasayama-shi, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Chuo-Ku, Tokyo, Japan
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Tokyo, , Japan
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Gdansk, , Poland
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Krakow, , Poland
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Siedlce, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Ponce, , Puerto Rico
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Sochi, , Russia
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Nitra-Zobor, , Slovakia
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Nové Zámky, , Slovakia
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Poprad, , Slovakia
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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L'Hospitalet de Llobregat, Barcelona, Spain
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Santander, Cantabria, Spain
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Córdoba, Cordoba, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Valencia, Valencia, Spain
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Fribourg, , Switzerland
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Zurich, , Switzerland
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Niao Sung Hsiang, Kaohsiung Hsien, Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Sumy, , Ukraine
Countries
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References
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Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2.
Related Links
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Other Identifiers
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A4021016
Identifier Type: -
Identifier Source: org_study_id
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