AzTrials
AzTrials

Carcinoma, Squamous CellPhase 3NCT00596830

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

A Phase 3 study testing CP-751,871 (Figitumumab), Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell and Carcinoma, Adenosquamous, run by Pfizer at 280 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CP-751,871 (Figitumumab), Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
681 participants
Where
280 sitesin 26 countries
Study dates
Apr 2008to Sep 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

280 sites in 26 countries.

280 sites in 26 countries

United States169 sites

  • Pfizer Investigational Site

    Alpharetta, Georgia, 30005

  • Pfizer Investigational Site

    Arlington, Virginia, 22205

  • Pfizer Investigational Site

    Arlington Heights, Illinois, 60005

  • Pfizer Investigational Site

    Atlanta, Georgia, 30318

  • Pfizer Investigational Site

    Atlanta, Georgia, 30341

  • Pfizer Investigational Site

    Atlanta, Georgia, 30342

  • Pfizer Investigational Site

    Aurora, Colorado, 80012

  • Pfizer Investigational Site

    Aurora, Illinois, 60504

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Austin, Texas, 78731

  • Pfizer Investigational Site

    Austin, Texas, 78745

  • Pfizer Investigational Site

    Austin, Texas, 78758

  • Pfizer Investigational Site

    Avon, Indiana, 46123

  • Pfizer Investigational Site

    Baltimore, Maryland, 21225

  • Pfizer Investigational Site

    Baltimore, Maryland, 21237

  • Pfizer Investigational Site

    Bartlett, Tennessee, 38133

  • Pfizer Investigational Site

    Beech Grove, Indiana, 46107

  • Pfizer Investigational Site

    Boulder, Colorado, 80303

  • Pfizer Investigational Site

    Bountiful, Utah, 84010

  • Pfizer Investigational Site

    Burlington, North Carolina, 27215

  • Pfizer Investigational Site

    Canton, Ohio, 44718

  • Pfizer Investigational Site

    Cedar Rapids, Iowa, 52402

  • Pfizer Investigational Site

    Chicago, Illinois, 60637

  • Pfizer Investigational Site

    Christiansburg, Virginia, 24073

  • Pfizer Investigational Site

    Clairton, Pennsylvania, 15025

  • Pfizer Investigational Site

    Cleveland, Ohio, 44195

  • Pfizer Investigational Site

    Coeur d'Alene, Idaho, 83814

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80907

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80909

  • Pfizer Investigational Site

    Columbia, South Carolina, 29203

  • Pfizer Investigational Site

    Columbus, Mississippi, 39705

  • Pfizer Investigational Site

    Conyers, Georgia, 30094

  • Pfizer Investigational Site

    Corinth, Mississippi, 38834

  • Pfizer Investigational Site

    Cumming, Georgia, 30041

  • Pfizer Investigational Site

    Dallas, Texas, 75230-2510

  • Pfizer Investigational Site

    Decatur, Georgia, 30033

  • Pfizer Investigational Site

    Denver, Colorado, 80218

  • Pfizer Investigational Site

    Denver, Colorado, 80220

  • Pfizer Investigational Site

    Detroit, Michigan, 48201

  • Pfizer Investigational Site

    Dover, Ohio, 44622

  • Pfizer Investigational Site

    Duluth, Georgia, 30096

  • Pfizer Investigational Site

    Elk Grove Village, Illinois, 60007

  • Pfizer Investigational Site

    Fairfax, Virginia, 22031

  • Pfizer Investigational Site

    Farmington Hills, Michigan, 48334

  • Pfizer Investigational Site

    Florence, Alabama, 35630

  • Pfizer Investigational Site

    Fort Sam Houston, Texas, 78234

  • Pfizer Investigational Site

    Fort Worth, Texas, 76111

  • Pfizer Investigational Site

    Fort Worth, Texas, 76177

  • Pfizer Investigational Site

    Gainesville, Virginia, 20155

  • Pfizer Investigational Site

    Galesburg, Illinois, 61401

  • Pfizer Investigational Site

    Grapevine, Texas, 76051

  • Pfizer Investigational Site

    Greensburg, Pennsylvania, 15601

  • Pfizer Investigational Site

    Hobart, Indiana, 46342

  • Pfizer Investigational Site

    Hobart, Indiana, 46432

  • Pfizer Investigational Site

    Hot Springs, Arkansas, 71913

  • Pfizer Investigational Site

    Houston, Texas, 77030

  • Pfizer Investigational Site

    Hudson, Florida, 34667

  • Pfizer Investigational Site

    Huntsville, Alabama, 35805

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46237

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46260

  • Pfizer Investigational Site

    Irving, Texas, 75063

  • Pfizer Investigational Site

    Jacksonville, Florida, 32207

  • Pfizer Investigational Site

    Johnstown, Pennsylvania, 15901

  • Pfizer Investigational Site

    Kansas City, Kansas, 66112

  • Pfizer Investigational Site

    Kansas City, Missouri, 64131

  • Pfizer Investigational Site

    Kansas City, Missouri, 64154

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37909

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37916

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37932

  • Pfizer Investigational Site

    Lake City, Florida, 32024

  • Pfizer Investigational Site

    Lake City, Florida, 32055

  • Pfizer Investigational Site

    Lake Spivey, Georgia, 30236

  • Pfizer Investigational Site

    Lake Success, New York, 11042

  • Pfizer Investigational Site

    Lakewood, Colorado, 80228

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89102

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89106

  • Pfizer Investigational Site

    Lawrence, Massachusetts, 01842

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30046

  • Pfizer Investigational Site

    Layton, Utah, 84041

  • Pfizer Investigational Site

    Lebanon, New Hampshire, 03756-0001

  • Pfizer Investigational Site

    Lee's Summit, Missouri, 64064

  • Pfizer Investigational Site

    Leesburg, Virginia, 20176

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68506

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68510

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68516

  • Pfizer Investigational Site

    Littleton, Colorado, 80120

  • Pfizer Investigational Site

    Lone Tree, Colorado, 80124

  • Pfizer Investigational Site

    Longmont, Colorado, 80501

  • Pfizer Investigational Site

    Longview, Texas, 75601

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Macon, Georgia, 31217

  • Pfizer Investigational Site

    Manchester, New Hampshire, 03102

  • Pfizer Investigational Site

    Manhasset, New York, 11030

  • Pfizer Investigational Site

    Marietta, Georgia, 30060

  • Pfizer Investigational Site

    Maryville, Tennessee, 37804

  • Pfizer Investigational Site

    McKeesport, Pennsylvania, 15132

  • Pfizer Investigational Site

    Memphis, Tennessee, 38119

  • Pfizer Investigational Site

    Memphis, Tennessee, 38120

  • Pfizer Investigational Site

    Miramar Beach, Florida, 32550

  • Pfizer Investigational Site

    Mooresville, Indiana, 46158-1737

  • Pfizer Investigational Site

    Mooresville, Indiana, 46158

  • Pfizer Investigational Site

    Munster, Indiana, 46321

  • Pfizer Investigational Site

    Murray, Utah, 84157

  • Pfizer Investigational Site

    Muscle Shoals, Alabama, 35661

  • Pfizer Investigational Site

    New Hyde Park, New York, 11040

  • Pfizer Investigational Site

    New Port Richey, Florida, 34655

  • Pfizer Investigational Site

    Norwalk, Connecticut, 06856

  • Pfizer Investigational Site

    Norwich, Connecticut, 06360

  • Pfizer Investigational Site

    Oneida, New York, 13421

  • Pfizer Investigational Site

    Orlando, Florida, 32803

  • Pfizer Investigational Site

    Orlando, Florida, 32804

  • Pfizer Investigational Site

    Oswego, New York, 13126

  • Pfizer Investigational Site

    Overland Park, Kansas, 66210

  • Pfizer Investigational Site

    Oxford, Mississippi, 38655

  • Pfizer Investigational Site

    Parker, Colorado, 80138

  • Pfizer Investigational Site

    Pensacola, Florida, 32504

  • Pfizer Investigational Site

    Pensacola, Florida, 32514

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19106

  • Pfizer Investigational Site

    Phoenix, Arizona, 85012

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15215

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15237

  • Pfizer Investigational Site

    Plano, Texas, 75075-7787

  • Pfizer Investigational Site

    Port Saint Lucie, Florida, 34952

  • Pfizer Investigational Site

    Provo, Utah, 84604

  • Pfizer Investigational Site

    Quincy, Massachusetts, 02169

  • Pfizer Investigational Site

    Radnor, Pennsylvania, 19087

  • Pfizer Investigational Site

    Roanoke, Virginia, 24014

  • Pfizer Investigational Site

    Round Rock, Texas, 78665

  • Pfizer Investigational Site

    Round Rock, Texas, 78681

  • Pfizer Investigational Site

    Saint Joseph, Michigan, 49085

  • Pfizer Investigational Site

    Saint Louis Park, Minnesota, 55426

  • Pfizer Investigational Site

    Salem, Virginia, 24153

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84102

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84106

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Marcos, Texas, 78666

  • Pfizer Investigational Site

    Sayre, Pennsylvania, 18840

  • Pfizer Investigational Site

    Scottsdale, Arizona, 85258

  • Pfizer Investigational Site

    Seattle, Washington, 98104

  • Pfizer Investigational Site

    Seattle, Washington, 98122

  • Pfizer Investigational Site

    Shawnee Mission, Kansas, 66204

  • Pfizer Investigational Site

    Snellville, Georgia, 30078

  • Pfizer Investigational Site

    Southaven, Mississippi, 38671

  • Pfizer Investigational Site

    Spokane, Washington, 99216

  • Pfizer Investigational Site

    Spokane, Washington, 99218

  • Pfizer Investigational Site

    Spokane Valley, Washington, 99202

  • Pfizer Investigational Site

    Spring Hill, Florida, 34608

  • Pfizer Investigational Site

    Stoneham, Massachusetts, 02180

  • Pfizer Investigational Site

    Sumter, South Carolina, 29150

  • Pfizer Investigational Site

    Syracuse, New York, 13210-2306

  • Pfizer Investigational Site

    Syracuse, New York, 13210

  • Pfizer Investigational Site

    Thornton, Colorado, 80260

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74133

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74136

  • Pfizer Investigational Site

    Tupelo, Mississippi, 38801

  • Pfizer Investigational Site

    Tyler, Texas, 75702

  • Pfizer Investigational Site

    West Valley City, Utah, 84120

  • Pfizer Investigational Site

    Wexford, Pennsylvania, 15090

  • Pfizer Investigational Site

    Weymouth, Massachusetts, 02189

  • Pfizer Investigational Site

    Winchester, Virginia, 22601

  • Pfizer Investigational Site

    Winfield, Illinois, 60190

  • Pfizer Investigational Site

    Woodbridge, Virginia, 22191

  • Pfizer Investigational Site

    Worcester, Massachusetts, 01605

  • Pfizer Investigational Site

    Wytheville, Virginia, 24382

  • Pfizer Investigational Site

    Yorkville, Illinois, 60560

Other trials in United States

Japan11 sites

  • Pfizer Investigational Site

    Akashi, Hyōgo

  • Pfizer Investigational Site

    Chuo-Ku, Tokyo

  • Pfizer Investigational Site

    Gifu, Gifu

  • Pfizer Investigational Site

    Kashiwa, Chiba

  • Pfizer Investigational Site

    Matsuyama, Ehime

  • Pfizer Investigational Site

    Osaka, Osaka

  • Pfizer Investigational Site

    Osakasayama-shi, Osaka

  • Pfizer Investigational Site

    Sakai-shi, Osaka

  • Pfizer Investigational Site

    Sapporo, Hokkaido

  • Pfizer Investigational Site

    Tokyo

  • Pfizer Investigational Site

    Yokohama, Kanagawa

Other trials in Japan

France9 sites

  • Pfizer Investigational Site

    Caen, 14033

  • Pfizer Investigational Site

    Caen, 14076

  • Pfizer Investigational Site

    Clermond-Ferrand Cedex 01, 63003

  • Pfizer Investigational Site

    Dijon, 21079

  • Pfizer Investigational Site

    Lyon, 69317

  • Pfizer Investigational Site

    Nantes, 44202

  • Pfizer Investigational Site

    Rennes, 35033

  • Pfizer Investigational Site

    Saint Pierre La Réunion Cedex, 97448

  • Pfizer Investigational Site

    Saint-Herblain, 44805

Other trials in France

Poland7 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Krakow, 31-115

  • Pfizer Investigational Site

    Siedlce, 08-110

  • Pfizer Investigational Site

    Warsaw, 01-138

  • Pfizer Investigational Site

    Warsaw, 02-097

  • Pfizer Investigational Site

    Warsaw, 02-781

  • Pfizer Investigational Site

    Wroclaw, 53-439

Other trials in Poland

Russia7 sites

  • Pfizer Investigational Site

    Moscow, 111033

  • Pfizer Investigational Site

    Moscow, 115478

  • Pfizer Investigational Site

    Saint Petersburg, 194044

  • Pfizer Investigational Site

    Saint Petersburg, 197089

  • Pfizer Investigational Site

    Saint Petersburg, 198255

  • Pfizer Investigational Site

    Samara, 443066

  • Pfizer Investigational Site

    Sochi, 354057

Other trials in Russia

Brazil6 sites

  • Pfizer Investigational Site

    Higienópolis, Sao Paulo/ Brazil, 01224-010

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20231 -050

  • Pfizer Investigational Site

    São Paulo, São Paulo, 01219-000

  • Pfizer Investigational Site

    São Paulo, São Paulo, 01221-020

  • Pfizer Investigational Site

    São Paulo, São Paulo, 01224-010

Other trials in Brazil

Spain6 sites

  • Pfizer Investigational Site

    Córdoba, Cordoba, 14004

  • Pfizer Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Pfizer Investigational Site

    Madrid, Madrid, 28033

  • Pfizer Investigational Site

    Pamplona, Navarre, 31008

  • Pfizer Investigational Site

    Santander, Cantabria, 39008

  • Pfizer Investigational Site

    Valencia, Valencia, 46010

Other trials in Spain

Germany5 sites

  • Pfizer Investigational Site

    Großhansdorf, 22927

  • Pfizer Investigational Site

    Karlsruhe, 76137

  • Pfizer Investigational Site

    Leipzig, 04207

  • Pfizer Investigational Site

    Mainz, 55131

  • Pfizer Investigational Site

    Oldenburg, 26121

Other trials in Germany

Hungary5 sites

  • Pfizer Investigational Site

    Budapest, 1525

  • Pfizer Investigational Site

    Deszk, 6772

  • Pfizer Investigational Site

    Székesfehérvár, 8000

  • Pfizer Investigational Site

    Szombathely, 9700

  • Pfizer Investigational Site

    Törökbálint, 2045

Other trials in Hungary

India5 sites

  • Pfizer Investigational Site

    Bangalore, Karnataka, 560 078

  • Pfizer Investigational Site

    Mumbai, Maharashtra, 400 012

  • Pfizer Investigational Site

    Nagpur, Maharashtra, 440012

  • Pfizer Investigational Site

    Navrangpura / Ahmedabad, Gujarat, 380 009

  • Pfizer Investigational Site

    New Delhi, New Delhi, 110 030

Other trials in India

Ukraine5 sites

  • Pfizer Investigational Site

    Dnipropetrovsk, 49102

  • Pfizer Investigational Site

    Donetsk, 83092

  • Pfizer Investigational Site

    Kyiv, 03115

  • Pfizer Investigational Site

    Lviv, 79031

  • Pfizer Investigational Site

    Sumy, 40005

Other trials in Ukraine

Australia4 sites

  • Pfizer Investigational Site

    Albury, New South Wales, 2640

  • Pfizer Investigational Site

    Geelong, Victoria, 3220

  • Pfizer Investigational Site

    Port Macquarie, New South Wales, 2444

  • Pfizer Investigational Site

    Wodonga, Victoria, 3690

Other trials in Australia

Bulgaria4 sites

  • Pfizer Investigational Site

    Sofia, Bulgaria, 1527

  • Pfizer Investigational Site

    Sofia, Bulgaria, 1756

  • Pfizer Investigational Site

    Sofia, 1233

  • Pfizer Investigational Site

    Varna, 9000

Other trials in Bulgaria

Czechia4 sites

  • Pfizer Investigational Site

    Nová Ves pod Pleší, 262 04

  • Pfizer Investigational Site

    Prague, 180 81

  • Pfizer Investigational Site

    Pribram I, 261 26

  • Pfizer Investigational Site

    Pribram V, 261 95

Other trials in Czechia

Greece4 sites

  • Pfizer Investigational Site

    Athens, 10676

  • Pfizer Investigational Site

    Athens, 11527

  • Pfizer Investigational Site

    Thessaloniki, Pylaia, 57001

  • Pfizer Investigational Site

    Thessaloniki, 56429

Other trials in Greece

Italy4 sites

  • Pfizer Investigational Site

    Genova, 16132

  • Pfizer Investigational Site

    Orbassano (TO), 10043

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Roma, 00152

Other trials in Italy

South Korea4 sites

  • Pfizer Investigational Site

    Gyeonggi-do, 410-769

  • Pfizer Investigational Site

    Seoul, 110-744

  • Pfizer Investigational Site

    Seoul, 135-710

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • Pfizer Investigational Site

    Niao Sung Hsiang, Kaohsiung Hsien, 833

  • Pfizer Investigational Site

    Tainan, 704

  • Pfizer Investigational Site

    Taipei, 100

  • Pfizer Investigational Site

    Taipei, 112

Other trials in Taiwan

Hong Kong3 sites

  • Pfizer Investigational Site

    Kowloon, 0

  • Pfizer Investigational Site

    Shatin, New Territories

  • Pfizer Investigational Site

    Tuenmen

Other trials in Hong Kong

Slovakia3 sites

  • Pfizer Investigational Site

    Nitra-Zobor, 949 88

  • Pfizer Investigational Site

    Nové Zámky, 94034

  • Pfizer Investigational Site

    Poprad, 058 01

Other trials in Slovakia

Austria2 sites

  • Pfizer Investigational Site

    Linz, A-4010

  • Pfizer Investigational Site

    Vienna, A-1090

Other trials in Austria

Canada2 sites

  • Pfizer Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • Pfizer Investigational Site

    Lévis, Quebec, G6V 3Z1

Other trials in Canada

Finland2 sites

  • Pfizer Investigational Site

    Helsinki, 00290

  • Pfizer Investigational Site

    Pori, 28500

Other trials in Finland

Switzerland2 sites

  • Pfizer Investigational Site

    Fribourg, 1708

  • Pfizer Investigational Site

    Zurich, 8091

Other trials in Switzerland

Turkey (Türkiye)2 sites

  • Pfizer Investigational Site

    Adana, 01330

  • Pfizer Investigational Site

    Ankara, 06100

Other trials in Turkey (Türkiye)

Puerto Rico1 site

  • Pfizer Investigational Site

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Being tested
CP-751,871 (Figitumumab), Carboplatin, Paclitaxel
Keywords
IGF-1R inhibitor, Non-small-cell lung carcinoma, CP-751, 871
Medical subject headings
Carcinoma, Squamous Cell, Carcinoma, Adenosquamous, Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-751,871 (Figitumumab)Drug

    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.

  • CarboplatinDrug

    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.

  • PaclitaxelDrug

    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.

  • CarboplatinDrug

    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.

  • PaclitaxelDrug

    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.

Study groups in NCT00596830
Study groupRoleWhat they receive
AExperimentalPatients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
Receives: Drug: CP-751,871 (Figitumumab); Drug: Carboplatin; Drug: Paclitaxel
BActive comparatorPatient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
Receives: Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline until death, assessed monthly after end of treatment, up to 30 months

Secondary outcomes (9)

  1. 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).

    Measured: At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. Maximum Observed Plasma Concentration (Cmax) for Figitumumab

    Measured: 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

  7. Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab

    Measured: 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

  8. 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.

    Measured: Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose

  9. Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels

    Measured: Cycles 1 and 4 (predose) and at end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMar 2011
  4. Study completionSep 2012

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
681 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00596830
Sponsor's protocol ID
A4021016
Status last verified
Dec 2013
First submitted
3 Jan 2008
Last updated
13 Jan 2014
Data monitoring committee
Yes

Publications

  • Roeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131.

    PubMed 41332393

  • Roeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11.

    PubMed 38468440

  • 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.

    PubMed 24888810

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CP-751,871 (Figitumumab), Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell and Carcinoma, Adenosquamous, run by Pfizer at 280 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 280 sites in United States, Japan, France, Poland, Russia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Baseline until death, assessed monthly after end of treatment, up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00596830, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.

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