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

December 11, 2013 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
681

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline until death, assessed monthly after end of treatment, up to 30 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose
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
Time Frame: Cycles 1 and 4 (predose) and at end of treatment
Cycles 1 and 4 (predose) and at end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4021016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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