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

NCT00596830 | Terminated Phase 3 Results DMC

• 1 other identifier: A4021016
• Study Type: interventional
• Target: 681
• Locations: 25 countries
• Sites: 276

Brief 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.

Conditions

Carcinoma, Squamous Cell; Carcinoma, Adenosquamous; Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung

Keywords

IGF-1R inhibitor; Non-small-cell lung carcinoma; CP-751; 871

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Progression-Free Survival (PFS)

  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)

  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)

  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

  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

  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

Study Arms (2)

A

EXPERIMENTAL

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); Drug: Carboplatin; Drug: Paclitaxel

B

ACTIVE COMPARATOR

Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Drug: Carboplatin; Drug: Paclitaxel

Interventions

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.

A

Carboplatin DRUG

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.

A

Paclitaxel DRUG

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (280)

Pfizer Investigational Site

Florence, Alabama, 35630, United States

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Huntsville, Alabama, 35805, United States

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Muscle Shoals, Alabama, 35661, United States

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Phoenix, Arizona, 85012, United States

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Scottsdale, Arizona, 85258, United States

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Hot Springs, Arkansas, 71913, United States

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Aurora, Colorado, 80012, United States

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Boulder, Colorado, 80303, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80220, United States

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Lakewood, Colorado, 80228, United States

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Littleton, Colorado, 80120, United States

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Lone Tree, Colorado, 80124, United States

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Longmont, Colorado, 80501, United States

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Parker, Colorado, 80138, United States

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Thornton, Colorado, 80260, United States

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Norwalk, Connecticut, 06856, United States

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Norwich, Connecticut, 06360, United States

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Hudson, Florida, 34667, United States

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Jacksonville, Florida, 32207, United States

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Lake City, Florida, 32024, United States

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Lake City, Florida, 32055, United States

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Miramar Beach, Florida, 32550, United States

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New Port Richey, Florida, 34655, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32804, United States

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Pensacola, Florida, 32504, United States

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Pensacola, Florida, 32514, United States

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Port Saint Lucie, Florida, 34952, United States

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Spring Hill, Florida, 34608, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30318, United States

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Atlanta, Georgia, 30341, United States

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Atlanta, Georgia, 30342, United States

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Conyers, Georgia, 30094, United States

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Cumming, Georgia, 30041, United States

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Decatur, Georgia, 30033, United States

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Duluth, Georgia, 30096, United States

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Lake Spivey, Georgia, 30236, United States

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Lawrenceville, Georgia, 30046, United States

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Macon, Georgia, 31217, United States

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Marietta, Georgia, 30060, United States

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Snellville, Georgia, 30078, United States

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Coeur d'Alene, Idaho, 83814, United States

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Arlington Heights, Illinois, 60005, United States

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Aurora, Illinois, 60504, United States

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Chicago, Illinois, 60637, United States

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Elk Grove Village, Illinois, 60007, United States

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Galesburg, Illinois, 61401, United States

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Winfield, Illinois, 60190, United States

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Yorkville, Illinois, 60560, United States

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Avon, Indiana, 46123, United States

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Beech Grove, Indiana, 46107, United States

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Hobart, Indiana, 46342, United States

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Hobart, Indiana, 46432, United States

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Indianapolis, Indiana, 46237, United States

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Indianapolis, Indiana, 46260, United States

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Mooresville, Indiana, 46158-1737, United States

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Mooresville, Indiana, 46158, United States

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Munster, Indiana, 46321, United States

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Cedar Rapids, Iowa, 52402, United States

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Kansas City, Kansas, 66112, United States

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Overland Park, Kansas, 66210, United States

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Shawnee Mission, Kansas, 66204, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Baltimore, Maryland, 21225, United States

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Baltimore, Maryland, 21237, United States

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Lawrence, Massachusetts, 01842, United States

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Quincy, Massachusetts, 02169, United States

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Stoneham, Massachusetts, 02180, United States

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Weymouth, Massachusetts, 02189, United States

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Worcester, Massachusetts, 01605, United States

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Detroit, Michigan, 48201, United States

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Farmington Hills, Michigan, 48334, United States

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Saint Joseph, Michigan, 49085, United States

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Saint Louis Park, Minnesota, 55426, United States

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Columbus, Mississippi, 39705, United States

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Corinth, Mississippi, 38834, United States

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Oxford, Mississippi, 38655, United States

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Southaven, Mississippi, 38671, United States

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Tupelo, Mississippi, 38801, United States

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Kansas City, Missouri, 64131, United States

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Kansas City, Missouri, 64154, United States

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Lee's Summit, Missouri, 64064, United States

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Lincoln, Nebraska, 68506, United States

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Lincoln, Nebraska, 68510, United States

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Lincoln, Nebraska, 68516, United States

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Las Vegas, Nevada, 89102, United States

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Las Vegas, Nevada, 89106, United States

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Lebanon, New Hampshire, 03756-0001, United States

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Manchester, New Hampshire, 03102, United States

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Lake Success, New York, 11042, United States

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Manhasset, New York, 11030, United States

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New Hyde Park, New York, 11040, United States

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Oneida, New York, 13421, United States

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Oswego, New York, 13126, United States

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Syracuse, New York, 13210-2306, United States

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Syracuse, New York, 13210, United States

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Burlington, North Carolina, 27215, United States

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Canton, Ohio, 44718, United States

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Cleveland, Ohio, 44195, United States

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Dover, Ohio, 44622, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74136, United States

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Clairton, Pennsylvania, 15025, United States

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Greensburg, Pennsylvania, 15601, United States

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Johnstown, Pennsylvania, 15901, United States

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McKeesport, Pennsylvania, 15132, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19106, United States

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Pittsburgh, Pennsylvania, 15215, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Pittsburgh, Pennsylvania, 15237, United States

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Radnor, Pennsylvania, 19087, United States

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Sayre, Pennsylvania, 18840, United States

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Wexford, Pennsylvania, 15090, United States

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Columbia, South Carolina, 29203, United States

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Sumter, South Carolina, 29150, United States

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Bartlett, Tennessee, 38133, United States

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Knoxville, Tennessee, 37909, United States

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Knoxville, Tennessee, 37916, United States

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Knoxville, Tennessee, 37932, United States

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Maryville, Tennessee, 37804, United States

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Memphis, Tennessee, 38119, United States

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Memphis, Tennessee, 38120, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78745, United States

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Austin, Texas, 78758, United States

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Dallas, Texas, 75230-2510, United States

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Fort Sam Houston, Texas, 78234, United States

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Fort Worth, Texas, 76111, United States

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Fort Worth, Texas, 76177, United States

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Grapevine, Texas, 76051, United States

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Houston, Texas, 77030, United States

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Irving, Texas, 75063, United States

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Longview, Texas, 75601, United States

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Plano, Texas, 75075-7787, United States

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Round Rock, Texas, 78665, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78229, United States

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San Marcos, Texas, 78666, United States

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Tyler, Texas, 75702, United States

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Bountiful, Utah, 84010, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84157, United States

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Provo, Utah, 84604, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84106, United States

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West Valley City, Utah, 84120, United States

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Arlington, Virginia, 22205, United States

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Christiansburg, Virginia, 24073, United States

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Fairfax, Virginia, 22031, United States

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Gainesville, Virginia, 20155, United States

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Leesburg, Virginia, 20176, United States

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Roanoke, Virginia, 24014, United States

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Salem, Virginia, 24153, United States

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Winchester, Virginia, 22601, United States

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Woodbridge, Virginia, 22191, United States

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Wytheville, Virginia, 24382, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Spokane, Washington, 99216, United States

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Spokane, Washington, 99218, United States

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Spokane Valley, Washington, 99202, United States

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Albury, New South Wales, 2640, Australia

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Port Macquarie, New South Wales, 2444, Australia

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Geelong, Victoria, 3220, Australia

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Wodonga, Victoria, 3690, Australia

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Linz, A-4010, Austria

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Vienna, A-1090, Austria

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Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil

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Higienópolis, Sao Paulo/ Brazil, 01224-010, Brazil

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São Paulo, São Paulo, 01219-000, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01224-010, Brazil

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Sofia, Bulgaria, 1527, Bulgaria

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Sofia, Bulgaria, 1756, Bulgaria

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Sofia, 1233, Bulgaria

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Varna, 9000, Bulgaria

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Edmonton, Alberta, T6G 1Z2, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Nová Ves pod Pleší, 262 04, Czechia

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Prague, 180 81, Czechia

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Pribram I, 261 26, Czechia

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Pribram V, 261 95, Czechia

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Helsinki, 00290, Finland

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Pori, 28500, Finland

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Caen, 14033, France

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Caen, 14076, France

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Clermond-Ferrand Cedex 01, 63003, France

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Dijon, 21079, France

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Lyon, 69317, France

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Nantes, 44202, France

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Rennes, 35033, France

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Saint Pierre La Réunion Cedex, 97448, France

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Saint-Herblain, 44805, France

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Großhansdorf, 22927, Germany

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Karlsruhe, 76137, Germany

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Leipzig, 04207, Germany

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Mainz, 55131, Germany

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Oldenburg, 26121, Germany

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Thessaloniki, Pylaia, 57001, Greece

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Athens, 10676, Greece

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Athens, 11527, Greece

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Thessaloniki, 56429, Greece

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Kowloon, 0, Hong Kong

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Shatin, New Territories, Hong Kong

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Tuenmen, Hong Kong

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Budapest, 1525, Hungary

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Deszk, 6772, Hungary

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Székesfehérvár, 8000, Hungary

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Szombathely, 9700, Hungary

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Törökbálint, 2045, Hungary

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Navrangpura / Ahmedabad, Gujarat, 380 009, India

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Bangalore, Karnataka, 560 078, India

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Mumbai, Maharashtra, 400 012, India

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Nagpur, Maharashtra, 440012, India

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New Delhi, New Delhi, 110 030, India

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Genova, 16132, Italy

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Orbassano (TO), 10043, Italy

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Padua, 35128, Italy

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Roma, 00152, Italy

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Gifu, Gifu, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Yokohama, Kanagawa, Japan

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Osaka, Osaka, Japan

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Osakasayama-shi, Osaka, Japan

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Sakai-shi, Osaka, Japan

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Chuo-Ku, Tokyo, Japan

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Tokyo, Japan

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Gdansk, 80-952, Poland

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Krakow, 31-115, Poland

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Siedlce, 08-110, Poland

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Warsaw, 01-138, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-781, Poland

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Wroclaw, 53-439, Poland

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Ponce, 00716, Puerto Rico

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Moscow, 111033, Russia

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Moscow, 115478, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197089, Russia

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Saint Petersburg, 198255, Russia

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Samara, 443066, Russia

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Sochi, 354057, Russia

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Nitra-Zobor, 949 88, Slovakia

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Nové Zámky, 94034, Slovakia

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Poprad, 058 01, Slovakia

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Gyeonggi-do, 410-769, South Korea

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Seoul, 110-744, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 39008, Spain

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Córdoba, Cordoba, 14004, Spain

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Madrid, Madrid, 28033, Spain

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Pamplona, Navarre, 31008, Spain

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Valencia, Valencia, 46010, Spain

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Fribourg, 1708, Switzerland

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Zurich, 8091, Switzerland

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Niao Sung Hsiang, Kaohsiung Hsien, 833, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Adana, 01330, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Dnipropetrovsk, 49102, Ukraine

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Donetsk, 83092, Ukraine

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Kyiv, 03115, Ukraine

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Lviv, 79031, Ukraine

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Sumy, 40005, Ukraine

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Related Publications (2)

• 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.

  PMID: 41332393 DERIVED

• 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.

  PMID: 24888810 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Carcinoma, Adenosquamous; Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung

Interventions

figitumumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms, Complex and Mixed; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

The study was terminated early due to futility. CP-751,871 will not undergo further development in the indication of advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 17, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 13, 2014
• Results First Posted: December 3, 2013

Record last verified: 2013-12

Locations

CZ (4); TW (4); TU (2); CA (2); HK (3); PL (7); BR (6); IT (4); RU (7); GR (4); KR (4); CH (2); SL (3); UA (5); FI (2); US (169); AU (2); HU (5); ES (6); IN (5); JP (11); PR (1); FR (9); DE (5); BU (4)