Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Adenosquamous; Carcinoma, Large Cell
• Intervention / Treatment: Drug: CP-751,871 (Figitumumab); Drug: Carboplatin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Paclitaxel

Detailed Description

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

• Study Type: Interventional
• Enrollment (Actual): 681
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Pfizer Investigational Site
    • Port Macquarie, New South Wales, Australia, 2444
      • Pfizer Investigational Site
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Pfizer Investigational Site
    • Wodonga, Victoria, Australia, 3690
      • Pfizer Investigational Site
• Austria
  • Linz, Austria, A-4010
    • Pfizer Investigational Site
  • Wien, Austria, A-1090
    • Pfizer Investigational Site
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20230-130
      • Pfizer Investigational Site
    • Rio de Janeiro, RJ, Brazil, 20231 -050
      • Pfizer Investigational Site
  • SP
    • Sao Paulo, SP, Brazil, 01224-010
      • Pfizer Investigational Site
    • Sao Paulo, SP, Brazil, 01221-020
      • Pfizer Investigational Site
    • Sao Paulo, SP, Brazil, 01219-000
      • Pfizer Investigational Site
  • Sao Paulo/ Brazil
    • Higienopolis, Sao Paulo/ Brazil, Brazil, 01224-010
      • Pfizer Investigational Site
• Bulgaria
  • Sofia, Bulgaria, 1233
    • Pfizer Investigational Site
  • Sofia, Bulgaria, 1527
    • Pfizer Investigational Site
  • Sofia, Bulgaria, 1756
    • Pfizer Investigational Site
  • Varna, Bulgaria, 9000
    • Pfizer Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Pfizer Investigational Site
  • Quebec
    • Levis, Quebec, Canada, G6V 3Z1
      • Pfizer Investigational Site
• Czech Republic
  • Nova Ves pod Plesi, Czech Republic, 262 04
    • Pfizer Investigational Site
  • Praha 8, Czech Republic, 180 81
    • Pfizer Investigational Site
  • Pribram I, Czech Republic, 261 26
    • Pfizer Investigational Site
  • Pribram V, Czech Republic, 261 95
    • Pfizer Investigational Site
• Finland
  • Helsinki, Finland, 00290
    • Pfizer Investigational Site
  • Pori, Finland, 28500
    • Pfizer Investigational Site
• France
  • Caen Cedex, France, 14033
    • Pfizer Investigational Site
  • Caen Cedex 05, France, 14076
    • Pfizer Investigational Site
  • Clermond-Ferrand Cedex 01, France, 63003
    • Pfizer Investigational Site
  • Dijon, France, 21079
    • Pfizer Investigational Site
  • Lyon Cedex 04, France, 69317
    • Pfizer Investigational Site
  • Nantes Cedex 2, France, 44202
    • Pfizer Investigational Site
  • Rennes Cedex 9, France, 35033
    • Pfizer Investigational Site
  • Saint Herblain Cedex, France, 44805
    • Pfizer Investigational Site
  • Saint Pierre la Réunion Cedex, France, 97448
    • Pfizer Investigational Site
• Germany
  • Grosshansdorf, Germany, 22927
    • Pfizer Investigational Site
  • Karlsruhe, Germany, 76137
    • Pfizer Investigational Site
  • Leipzig, Germany, 04207
    • Pfizer Investigational Site
  • Mainz, Germany, 55131
    • Pfizer Investigational Site
  • Oldenburg, Germany, 26121
    • Pfizer Investigational Site
• Greece
  • Athens, Greece, 11527
    • Pfizer Investigational Site
  • Athens, Greece, 10676
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 56429
    • Pfizer Investigational Site
  • Pylaia
    • Thessaloniki, Pylaia, Greece, 57001
      • Pfizer Investigational Site
• Hong Kong
  • Kowloon, Hong Kong
    • Pfizer Investigational Site
  • Shatin, New Territories, Hong Kong
    • Pfizer Investigational Site
  • Tuen Mun, Hong Kong
    • Pfizer Investigational Site
• Hungary
  • Budapest, Hungary, 1525
    • Pfizer Investigational Site
  • Deszk, Hungary, 6772
    • Pfizer Investigational Site
  • Szekesfehervar, Hungary, 8000
    • Pfizer Investigational Site
  • Szombathely, Hungary, 9700
    • Pfizer Investigational Site
  • Torokbalint, Hungary, 2045
    • Pfizer Investigational Site
• India
  • New Delhi, India, 110 030
    • Pfizer Investigational Site
  • Gujarat
    • Navrangpura / Ahmedabad, Gujarat, India, 380 009
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 078
      • Pfizer Investigational Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 012
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440012
      • Pfizer Investigational Site
• Italy
  • Genova, Italy, 16132
    • Pfizer Investigational Site
  • Orbassano (TO), Italy, 10043
    • Pfizer Investigational Site
  • Padova, Italy, 35128
    • Pfizer Investigational Site
  • Roma, Italy, 00152
    • Pfizer Investigational Site
• Japan
  • Tokyo, Japan
    • Pfizer Investigational Site
  • Chiba
    • Kashiwa, Chiba, Japan
      • Pfizer Investigational Site
  • Ehime
    • Matsuyama-shi, Ehime, Japan
      • Pfizer Investigational Site
  • Gifu
    • Gifu-shi, Gifu, Japan
      • Pfizer Investigational Site
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan
      • Pfizer Investigational Site
  • Hyogo
    • Akashi, Hyogo, Japan
      • Pfizer Investigational Site
  • Kanagawa
    • Yokohama-city, Kanagawa, Japan
      • Pfizer Investigational Site
  • Osaka
    • Osaka-city, Osaka, Japan
      • Pfizer Investigational Site
    • Osakasayama-shi, Osaka, Japan
      • Pfizer Investigational Site
  • Osaka-fu
    • Sakai-shi, Osaka-fu, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Chuo-Ku, Tokyo, Japan
      • Pfizer Investigational Site
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 410-769
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
• Poland
  • Gdansk, Poland, 80-952
    • Pfizer Investigational Site
  • Krakow, Poland, 31-115
    • Pfizer Investigational Site
  • Siedlce, Poland, 08-110
    • Pfizer Investigational Site
  • Warszawa, Poland, 02-781
    • Pfizer Investigational Site
  • Warszawa, Poland, 02-097
    • Pfizer Investigational Site
  • Warszawa, Poland, 01-138
    • Pfizer Investigational Site
  • Wroclaw, Poland, 53-439
    • Pfizer Investigational Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 111033
    • Pfizer Investigational Site
  • Saint-Petersburg, Russian Federation, 197089
    • Pfizer Investigational Site
  • Samara, Russian Federation, 443066
    • Pfizer Investigational Site
  • Sochi, Russian Federation, 354057
    • Pfizer Investigational Site
  • St-Petersburg, Russian Federation, 194044
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 198255
    • Pfizer Investigational Site
• Slovakia
  • Nitra-Zobor, Slovakia, 949 88
    • Pfizer Investigational Site
  • Nove Zamky, Slovakia, 94034
    • Pfizer Investigational Site
  • Poprad, Slovakia, 058 01
    • Pfizer Investigational Site
• Spain
  • Cordoba, Spain, 14004
    • Pfizer Investigational Site
  • Madrid, Spain, 28033
    • Pfizer Investigational Site
  • Valencia, Spain, 46010
    • Pfizer Investigational Site
  • Barcelona
    • L'hospitalet de Llobregat, Barcelona, Spain, 08907
      • Pfizer Investigational Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Pfizer Investigational Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Pfizer Investigational Site
• Switzerland
  • Fribourg, Switzerland, 1708
    • Pfizer Investigational Site
  • Zuerich, Switzerland, 8091
    • Pfizer Investigational Site
• Taiwan
  • Tainan, Taiwan, 704
    • Pfizer Investigational Site
  • Taipei, Taiwan, 100
    • Pfizer Investigational Site
  • Taipei, Taiwan, 112
    • Pfizer Investigational Site
  • Kaohsiung Hsien
    • Niao Sung Hsiang, Kaohsiung Hsien, Taiwan, 833
      • Pfizer Investigational Site
• Turkey
  • Adana, Turkey, 01330
    • Pfizer Investigational Site
  • Ankara, Turkey, 06100
    • Pfizer Investigational Site
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • Pfizer Investigational Site
  • Donetsk, Ukraine, 83092
    • Pfizer Investigational Site
  • Kyiv, Ukraine, 03115
    • Pfizer Investigational Site
  • Lviv, Ukraine, 79031
    • Pfizer Investigational Site
  • Sumy, Ukraine, 40005
    • Pfizer Investigational Site
• United States
  • Alabama
    • Florence, Alabama, United States, 35630
      • Pfizer Investigational Site
    • Huntsville, Alabama, United States, 35805
      • Pfizer Investigational Site
    • Muscle Shoals, Alabama, United States, 35661
      • Pfizer Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Pfizer Investigational Site
    • Scottsdale, Arizona, United States, 85258
      • Pfizer Investigational Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Pfizer Investigational Site
    • Boulder, Colorado, United States, 80303
      • Pfizer Investigational Site
    • Colorado Springs, Colorado, United States, 80907
      • Pfizer Investigational Site
    • Colorado Springs, Colorado, United States, 80909
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80220
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80218
      • Pfizer Investigational Site
    • Lakewood, Colorado, United States, 80228
      • Pfizer Investigational Site
    • Littleton, Colorado, United States, 80120
      • Pfizer Investigational Site
    • Lone Tree, Colorado, United States, 80124
      • Pfizer Investigational Site
    • Longmont, Colorado, United States, 80501
      • Pfizer Investigational Site
    • Parker, Colorado, United States, 80138
      • Pfizer Investigational Site
    • Thornton, Colorado, United States, 80260
      • Pfizer Investigational Site
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Pfizer Investigational Site
    • Norwich, Connecticut, United States, 06360
      • Pfizer Investigational Site
  • Florida
    • Hudson, Florida, United States, 34667
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32207
      • Pfizer Investigational Site
    • Lake City, Florida, United States, 32024
      • Pfizer Investigational Site
    • Lake City, Florida, United States, 32055
      • Pfizer Investigational Site
    • Miramar Beach, Florida, United States, 32550
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34655
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32804
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32803
      • Pfizer Investigational Site
    • Pensacola, Florida, United States, 32504
      • Pfizer Investigational Site
    • Pensacola, Florida, United States, 32514
      • Pfizer Investigational Site
    • Port St. Lucie, Florida, United States, 34952
      • Pfizer Investigational Site
    • Spring Hill, Florida, United States, 34608
      • Pfizer Investigational Site
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30341
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30318
      • Pfizer Investigational Site
    • Conyers, Georgia, United States, 30094
      • Pfizer Investigational Site
    • Cumming, Georgia, United States, 30041
      • Pfizer Investigational Site
    • Decatur, Georgia, United States, 30033
      • Pfizer Investigational Site
    • Duluth, Georgia, United States, 30096
      • Pfizer Investigational Site
    • Lake Spivey, Georgia, United States, 30236
      • Pfizer Investigational Site
    • Lawrenceville, Georgia, United States, 30046
      • Pfizer Investigational Site
    • Macon, Georgia, United States, 31217
      • Pfizer Investigational Site
    • Marietta, Georgia, United States, 30060
      • Pfizer Investigational Site
    • Snellville, Georgia, United States, 30078
      • Pfizer Investigational Site
  • Idaho
    • Coeur d' Alene, Idaho, United States, 83814
      • Pfizer Investigational Site
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Pfizer Investigational Site
    • Aurora, Illinois, United States, 60504
      • Pfizer Investigational Site
    • Chicago, Illinois, United States, 60637
      • Pfizer Investigational Site
    • Elk Grove Village, Illinois, United States, 60007
      • Pfizer Investigational Site
    • Galesburg, Illinois, United States, 61401
      • Pfizer Investigational Site
    • Winfield, Illinois, United States, 60190
      • Pfizer Investigational Site
    • Yorkville, Illinois, United States, 60560
      • Pfizer Investigational Site
  • Indiana
    • Avon, Indiana, United States, 46123
      • Pfizer Investigational Site
    • Beech Grove, Indiana, United States, 46107
      • Pfizer Investigational Site
    • Hobart, Indiana, United States, 46342
      • Pfizer Investigational Site
    • Hobart, Indiana, United States, 46432
      • Pfizer Investigational Site
    • Indianapolis, Indiana, United States, 46260
      • Pfizer Investigational Site
    • Indianapolis, Indiana, United States, 46237
      • Pfizer Investigational Site
    • Mooresville, Indiana, United States, 46158
      • Pfizer Investigational Site
    • Mooresville, Indiana, United States, 46158-1737
      • Pfizer Investigational Site
    • Munster, Indiana, United States, 46321
      • Pfizer Investigational Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52402
      • Pfizer Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66112
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66210
      • Pfizer Investigational Site
    • Shawnee Mission, Kansas, United States, 66204
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40207
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21225
      • Pfizer Investigational Site
  • Massachusetts
    • Lawrence, Massachusetts, United States, 01842
      • Pfizer Investigational Site
    • Quincy, Massachusetts, United States, 02169
      • Pfizer Investigational Site
    • Stoneham, Massachusetts, United States, 02180
      • Pfizer Investigational Site
    • Weymouth, Massachusetts, United States, 02189
      • Pfizer Investigational Site
    • Worcester, Massachusetts, United States, 01605
      • Pfizer Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Pfizer Investigational Site
    • Farmington Hills, Michigan, United States, 48334
      • Pfizer Investigational Site
    • St. Joseph, Michigan, United States, 49085
      • Pfizer Investigational Site
  • Minnesota
    • St. Louis Park, Minnesota, United States, 55426
      • Pfizer Investigational Site
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Pfizer Investigational Site
    • Corinth, Mississippi, United States, 38834
      • Pfizer Investigational Site
    • Oxford, Mississippi, United States, 38655
      • Pfizer Investigational Site
    • Southaven, Mississippi, United States, 38671
      • Pfizer Investigational Site
    • Tupelo, Mississippi, United States, 38801
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Pfizer Investigational Site
    • Kansas City, Missouri, United States, 64154
      • Pfizer Investigational Site
    • Lee's Summit, Missouri, United States, 64064
      • Pfizer Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Pfizer Investigational Site
    • Lincoln, Nebraska, United States, 68510
      • Pfizer Investigational Site
    • Lincoln, Nebraska, United States, 68516
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89106
      • Pfizer Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
      • Pfizer Investigational Site
    • Manchester, New Hampshire, United States, 03102
      • Pfizer Investigational Site
  • New York
    • Lake Success, New York, United States, 11042
      • Pfizer Investigational Site
    • Manhasset, New York, United States, 11030
      • Pfizer Investigational Site
    • New Hyde Park, New York, United States, 11040
      • Pfizer Investigational Site
    • Oneida, New York, United States, 13421
      • Pfizer Investigational Site
    • Oswego, New York, United States, 13126
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210-2306
      • Pfizer Investigational Site
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Pfizer Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44195
      • Pfizer Investigational Site
    • Dover, Ohio, United States, 44622
      • Pfizer Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74136
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74104
      • Pfizer Investigational Site
  • Pennsylvania
    • Clairton, Pennsylvania, United States, 15025
      • Pfizer Investigational Site
    • Greensburg, Pennsylvania, United States, 15601
      • Pfizer Investigational Site
    • Johnstown, Pennsylvania, United States, 15901
      • Pfizer Investigational Site
    • McKeesport, Pennsylvania, United States, 15132
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19106
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15232
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15215
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15237
      • Pfizer Investigational Site
    • Radnor, Pennsylvania, United States, 19087
      • Pfizer Investigational Site
    • Sayre, Pennsylvania, United States, 18840
      • Pfizer Investigational Site
    • Wexford, Pennsylvania, United States, 15090
      • Pfizer Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Pfizer Investigational Site
    • Sumter, South Carolina, United States, 29150
      • Pfizer Investigational Site
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States, 37916
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States, 37909
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States, 37932
      • Pfizer Investigational Site
    • Maryville, Tennessee, United States, 37804
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38119
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38120
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78745
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78731
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78758
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75230-2510
      • Pfizer Investigational Site
    • Fort Sam Houston, Texas, United States, 78234
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76177
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76111
      • Pfizer Investigational Site
    • Grapevine, Texas, United States, 76051
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030
      • Pfizer Investigational Site
    • Irving, Texas, United States, 75063
      • Pfizer Investigational Site
    • Longview, Texas, United States, 75601
      • Pfizer Investigational Site
    • Plano, Texas, United States, 75075-7787
      • Pfizer Investigational Site
    • Round Rock, Texas, United States, 78665
      • Pfizer Investigational Site
    • Round Rock, Texas, United States, 78681
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
    • San Marcos, Texas, United States, 78666
      • Pfizer Investigational Site
    • Tyler, Texas, United States, 75702
      • Pfizer Investigational Site
  • Utah
    • Bountiful, Utah, United States, 84010
      • Pfizer Investigational Site
    • Layton, Utah, United States, 84041
      • Pfizer Investigational Site
    • Murray, Utah, United States, 84157
      • Pfizer Investigational Site
    • Provo, Utah, United States, 84604
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84106
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84102
      • Pfizer Investigational Site
    • West Valley City, Utah, United States, 84120
      • Pfizer Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Pfizer Investigational Site
    • Christiansburg, Virginia, United States, 24073
      • Pfizer Investigational Site
    • Fairfax, Virginia, United States, 22031
      • Pfizer Investigational Site
    • Gainesville, Virginia, United States, 20155
      • Pfizer Investigational Site
    • Leesburg, Virginia, United States, 20176
      • Pfizer Investigational Site
    • Roanoke, Virginia, United States, 24014
      • Pfizer Investigational Site
    • Salem, Virginia, United States, 24153
      • Pfizer Investigational Site
    • Winchester, Virginia, United States, 22601
      • Pfizer Investigational Site
    • Woodbridge, Virginia, United States, 22191
      • Pfizer Investigational Site
    • Wytheville, Virginia, United States, 24382
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Pfizer Investigational Site
    • Seattle, Washington, United States, 98122
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99216
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99218
      • Pfizer Investigational Site
    • Spokane Valley, Washington, United States, 99202
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
• 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 with symptomatic central nervous system (CNS) metastases are not permitted.
• Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
• Patients with other active cancer types are not permitted.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.'	Drug: 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.; Drug: 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.; Drug: 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.; Drug: 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.; Drug: 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.
Active Comparator: B; Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.	Drug: 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.; Drug: 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.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.	Baseline until death, assessed monthly after end of treatment, up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).	At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.
Percentage of Participants With Objective Response (OR)	Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.	At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.	Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.	Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.	Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Maximum Observed Plasma Concentration (Cmax) for Figitumumab		Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab		Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Number of Participants With Total Anti-drug Antibodies (ADA)	ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.	Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose
Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels		Cycles 1 and 4 (predose) and at end of treatment

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: January 8, 2008
• First Posted (Estimate): January 17, 2008

Study Record Updates

• Last Update Posted (Estimate): January 13, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: IGF-1R inhibitor; CP-751; 871; Non-small-cell lung carcinoma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasms, Complex and Mixed; Neoplasms, Squamous Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Adenosquamous; Carcinoma, Large Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: A4021016