Lung Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

681

Study ID:

NCT00596830

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 264 Locations for this study

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Pfizer Investigational Site
Florence Alabama, 35630, United States
Pfizer Investigational Site
Huntsville Alabama, 35805, United States
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Muscle Shoals Alabama, 35661, United States
Pfizer Investigational Site
Phoenix Arizona, 85012, United States
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Scottsdale Arizona, 85258, United States
Pfizer Investigational Site
Hot Springs Arkansas, 71913, United States
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Aurora Colorado, 80012, United States
Pfizer Investigational Site
Boulder Colorado, 80303, United States
Pfizer Investigational Site
Colorado Springs Colorado, 80907, United States
Pfizer Investigational Site
Colorado Springs Colorado, 80909, United States
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Denver Colorado, 80218, United States
Pfizer Investigational Site
Denver Colorado, 80220, United States
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Lakewood Colorado, 80228, United States
Pfizer Investigational Site
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
Pfizer Investigational Site
Hudson Florida, 34667, United States
Pfizer Investigational Site
Jacksonville Florida, 32207, United States
Pfizer Investigational Site
Lake City Florida, 32024, United States
Pfizer Investigational Site
Lake City Florida, 32055, United States
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Miramar Beach Florida, 32550, United States
Pfizer Investigational Site
New Port Richey Florida, 34655, United States
Pfizer Investigational Site
Orlando Florida, 32803, United States
Pfizer Investigational Site
Orlando Florida, 32804, United States
Pfizer Investigational Site
Pensacola Florida, 32504, United States
Pfizer Investigational Site
Pensacola Florida, 32514, United States
Pfizer Investigational Site
Port St. Lucie Florida, 34952, United States
Pfizer Investigational Site
Spring Hill Florida, 34608, United States
Pfizer Investigational Site
Alpharetta Georgia, 30005, United States
Pfizer Investigational Site
Atlanta Georgia, 30318, United States
Pfizer Investigational Site
Atlanta Georgia, 30341, United States
Pfizer Investigational Site
Atlanta Georgia, 30342, United States
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Conyers Georgia, 30094, United States
Pfizer Investigational Site
Cumming Georgia, 30041, United States
Pfizer Investigational Site
Decatur Georgia, 30033, United States
Pfizer Investigational Site
Duluth Georgia, 30096, United States
Pfizer Investigational Site
Lake Spivey Georgia, 30236, United States
Pfizer Investigational Site
Lawrenceville Georgia, 30046, United States
Pfizer Investigational Site
Macon Georgia, 31217, United States
Pfizer Investigational Site
Marietta Georgia, 30060, United States
Pfizer Investigational Site
Snellville Georgia, 30078, United States
Pfizer Investigational Site
Coeur d' Alene Idaho, 83814, United States
Pfizer Investigational Site
Arlington Heights Illinois, 60005, United States
Pfizer Investigational Site
Aurora Illinois, 60504, United States
Pfizer Investigational Site
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
Pfizer Investigational Site
Hobart Indiana, 46342, United States
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Hobart Indiana, 46432, United States
Pfizer Investigational Site
Indianapolis Indiana, 46237, United States
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Indianapolis Indiana, 46260, United States
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Mooresville Indiana, 46158, United States
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Mooresville Indiana, 46158, United States
Pfizer Investigational Site
Munster Indiana, 46321, United States
Pfizer Investigational Site
Cedar Rapids Iowa, 52402, United States
Pfizer Investigational Site
Kansas City Kansas, 66112, United States
Pfizer Investigational Site
Overland Park Kansas, 66210, United States
Pfizer Investigational Site
Shawnee Mission Kansas, 66204, United States
Pfizer Investigational Site
Louisville Kentucky, 40202, United States
Pfizer Investigational Site
Louisville Kentucky, 40207, United States
Pfizer Investigational Site
Baltimore Maryland, 21225, United States
Pfizer Investigational Site
Baltimore Maryland, 21237, United States
Pfizer Investigational Site
Lawrence Massachusetts, 01842, United States
Pfizer Investigational Site
Quincy Massachusetts, 02169, United States
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Stoneham Massachusetts, 02180, United States
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Weymouth Massachusetts, 02189, United States
Pfizer Investigational Site
Worcester Massachusetts, 01605, United States
Pfizer Investigational Site
Detroit Michigan, 48201, United States
Pfizer Investigational Site
Farmington Hills Michigan, 48334, United States
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St. Joseph Michigan, 49085, United States
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St. Louis Park Minnesota, 55426, United States
Pfizer Investigational Site
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
Pfizer Investigational Site
Kansas City Missouri, 64131, United States
Pfizer Investigational Site
Kansas City Missouri, 64154, United States
Pfizer Investigational Site
Lee's Summit Missouri, 64064, United States
Pfizer Investigational Site
Lincoln Nebraska, 68506, United States
Pfizer Investigational Site
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, United States
Pfizer Investigational Site
Manchester New Hampshire, 03102, United States
Pfizer Investigational Site
Lake Success New York, 11042, United States
Pfizer Investigational Site
Manhasset New York, 11030, United States
Pfizer Investigational Site
New Hyde Park New York, 11040, United States
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Oneida New York, 13421, United States
Pfizer Investigational Site
Oswego New York, 13126, United States
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Syracuse New York, 13210, United States
Pfizer Investigational Site
Syracuse New York, 13210, United States
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Burlington North Carolina, 27215, United States
Pfizer Investigational Site
Canton Ohio, 44718, United States
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Cleveland Ohio, 44195, United States
Pfizer Investigational Site
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
Pfizer Investigational Site
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
Pfizer Investigational Site
Philadelphia Pennsylvania, 19106, United States
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Pittsburgh Pennsylvania, 15215, United States
Pfizer Investigational Site
Pittsburgh Pennsylvania, 15232, United States
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Pittsburgh Pennsylvania, 15237, United States
Pfizer Investigational Site
Radnor Pennsylvania, 19087, United States
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Sayre Pennsylvania, 18840, United States
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Wexford Pennsylvania, 15090, United States
Pfizer Investigational Site
Columbia South Carolina, 29203, United States
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Sumter South Carolina, 29150, United States
Pfizer Investigational Site
Bartlett Tennessee, 38133, United States
Pfizer Investigational Site
Knoxville Tennessee, 37909, United States
Pfizer Investigational Site
Knoxville Tennessee, 37916, United States
Pfizer Investigational Site
Knoxville Tennessee, 37932, United States
Pfizer Investigational Site
Maryville Tennessee, 37804, United States
Pfizer Investigational Site
Memphis Tennessee, 38119, United States
Pfizer Investigational Site
Memphis Tennessee, 38120, United States
Pfizer Investigational Site
Austin Texas, 78705, United States
Pfizer Investigational Site
Austin Texas, 78731, United States
Pfizer Investigational Site
Austin Texas, 78745, United States
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Austin Texas, 78758, United States
Pfizer Investigational Site
Dallas Texas, 75230, United States
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Fort Sam Houston Texas, 78234, United States
Pfizer Investigational Site
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
Pfizer Investigational Site
Irving Texas, 75063, United States
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Longview Texas, 75601, United States
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Plano Texas, 75075, United States
Pfizer Investigational Site
Round Rock Texas, 78665, United States
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Round Rock Texas, 78681, United States
Pfizer Investigational Site
San Antonio Texas, 78229, United States
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San Marcos Texas, 78666, United States
Pfizer Investigational Site
Tyler Texas, 75702, United States
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Bountiful Utah, 84010, United States
Pfizer Investigational Site
Layton Utah, 84041, United States
Pfizer Investigational Site
Murray Utah, 84157, United States
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Provo Utah, 84604, United States
Pfizer Investigational Site
Salt Lake City Utah, 84102, United States
Pfizer Investigational Site
Salt Lake City Utah, 84106, United States
Pfizer Investigational Site
West Valley City Utah, 84120, United States
Pfizer Investigational Site
Arlington Virginia, 22205, United States
Pfizer Investigational Site
Christiansburg Virginia, 24073, United States
Pfizer Investigational Site
Fairfax Virginia, 22031, United States
Pfizer Investigational Site
Gainesville Virginia, 20155, United States
Pfizer Investigational Site
Leesburg Virginia, 20176, United States
Pfizer Investigational Site
Roanoke Virginia, 24014, United States
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Salem Virginia, 24153, United States
Pfizer Investigational Site
Winchester Virginia, 22601, United States
Pfizer Investigational Site
Woodbridge Virginia, 22191, United States
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Wytheville Virginia, 24382, United States
Pfizer Investigational Site
Seattle Washington, 98104, United States
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Seattle Washington, 98122, United States
Pfizer Investigational Site
Spokane Valley Washington, 99202, United States
Pfizer Investigational Site
Spokane Washington, 99216, United States
Pfizer Investigational Site
Spokane Washington, 99218, United States
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Albury New South Wales, 2640, Australia
Pfizer Investigational Site
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-401, Austria
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Wien , A-109, Austria
Pfizer Investigational Site
Rio de Janeiro RJ, 20230, Brazil
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Rio de Janeiro RJ, 20231, Brazil
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Higienopolis Sao Paulo/ Brazil, 01224, Brazil
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Sao Paulo SP, 01219, Brazil
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Sao Paulo SP, 01221, Brazil
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Sao Paulo SP, 01224, Brazil
Pfizer Investigational Site
Sofia , 1233, Bulgaria
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Sofia , 1527, Bulgaria
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Sofia , 1756, Bulgaria
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Varna , 9000, Bulgaria
Pfizer Investigational Site
Edmonton Alberta, T6G 1, Canada
Pfizer Investigational Site
Levis Quebec, G6V 3, Canada
Pfizer Investigational Site
Nova Ves pod Plesi , 262 0, Czech Republic
Pfizer Investigational Site
Praha 8 , 180 8, Czech Republic
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Pribram I , 261 2, Czech Republic
Pfizer Investigational Site
Pribram V , 261 9, Czech Republic
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Helsinki , 00290, Finland
Pfizer Investigational Site
Pori , 28500, Finland
Pfizer Investigational Site
Caen Cedex 05 , 14076, France
Pfizer Investigational Site
Caen Cedex , 14033, France
Pfizer Investigational Site
Clermond-Ferrand Cedex 01 , 63003, France
Pfizer Investigational Site
Dijon , 21079, France
Pfizer Investigational Site
Lyon Cedex 04 , 69317, France
Pfizer Investigational Site
Nantes Cedex 2 , 44202, France
Pfizer Investigational Site
Rennes Cedex 9 , 35033, France
Pfizer Investigational Site
Saint Herblain Cedex , 44805, France
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Saint Pierre la Réunion Cedex , 97448, France
Pfizer Investigational Site
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
Pfizer Investigational Site
Thessaloniki Pylaia, 57001, Greece
Pfizer Investigational Site
Athens , 10676, Greece
Pfizer Investigational Site
Athens , 11527, Greece
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Thessaloniki , 56429, Greece
Pfizer Investigational Site
Kowloon , 0, Hong Kong
Pfizer Investigational Site
Shatin, New Territories , , Hong Kong
Pfizer Investigational Site
Tuen Mun , , Hong Kong
Pfizer Investigational Site
Budapest , 1525, Hungary
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Deszk , 6772, Hungary
Pfizer Investigational Site
Szekesfehervar , 8000, Hungary
Pfizer Investigational Site
Szombathely , 9700, Hungary
Pfizer Investigational Site
Torokbalint , 2045, Hungary
Pfizer Investigational Site
Navrangpura / Ahmedabad Gujarat, 380 0, India
Pfizer Investigational Site
Bangalore Karnataka, 560 0, India
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Mumbai Maharashtra, 400 0, India
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Nagpur Maharashtra, 44001, India
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New Delhi , 110 0, India
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Genova , 16132, Italy
Pfizer Investigational Site
Orbassano (TO) , 10043, Italy
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Padova , 35128, Italy
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Roma , 00152, Italy
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Kashiwa Chiba, , Japan
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Matsuyama-shi Ehime, , Japan
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Gifu-shi Gifu, , Japan
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Sapporo-shi Hokkaido, , Japan
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Akashi Hyogo, , Japan
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Yokohama-city Kanagawa, , Japan
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Sakai-shi Osaka-fu, , Japan
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Osaka-city Osaka, , Japan
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Osakasayama-shi Osaka, , Japan
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Chuo-Ku Tokyo, , Japan
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Tokyo , , Japan
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Gyeonggi-do , 410-7, Korea, Republic of
Pfizer Investigational Site
Seoul , 110-7, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
Pfizer Investigational Site
Seoul , 138-7, Korea, Republic of
Pfizer Investigational Site
Gdansk , 80-95, Poland
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Krakow , 31-11, Poland
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Siedlce , 08-11, Poland
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Warszawa , 01-13, Poland
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Warszawa , 02-09, Poland
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Warszawa , 02-78, Poland
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Wroclaw , 53-43, Poland
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Ponce , 00716, Puerto Rico
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Moscow , 11103, Russian Federation
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Moscow , 11547, Russian Federation
Pfizer Investigational Site
Saint-Petersburg , 19708, Russian Federation
Pfizer Investigational Site
Samara , 44306, Russian Federation
Pfizer Investigational Site
Sochi , 35405, Russian Federation
Pfizer Investigational Site
St-Petersburg , 19404, Russian Federation
Pfizer Investigational Site
St. Petersburg , 19825, Russian Federation
Pfizer Investigational Site
Nitra-Zobor , 949 8, Slovakia
Pfizer Investigational Site
Nove Zamky , 94034, Slovakia
Pfizer Investigational Site
Poprad , 058 0, Slovakia
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L'hospitalet de Llobregat Barcelona, 08907, Spain
Pfizer Investigational Site
Santander Cantabria, 39008, Spain
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Pamplona Navarra, 31008, Spain
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Cordoba , 14004, Spain
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Madrid , 28033, Spain
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Valencia , 46010, Spain
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Fribourg , 1708, Switzerland
Pfizer Investigational Site
Zuerich , 8091, Switzerland
Pfizer Investigational Site
Niao Sung Hsiang Kaohsiung Hsien, 833, Taiwan
Pfizer Investigational Site
Tainan , 704, Taiwan
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Taipei , 100, Taiwan
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Taipei , 112, Taiwan
Pfizer Investigational Site
Adana , 01330, Turkey
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Ankara , 06100, Turkey
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Dnipropetrovsk , 49102, Ukraine
Pfizer Investigational Site
Donetsk , 83092, Ukraine
Pfizer Investigational Site
Kyiv , 03115, Ukraine
Pfizer Investigational Site
Lviv , 79031, Ukraine
Pfizer Investigational Site
Sumy , 40005, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

681

Study ID:

NCT00596830

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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