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A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

NCT ID: NCT00457392

Last Updated: 2013-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-12-31

Brief Summary

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This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.

Detailed Description

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Conditions

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Carcinoma, Non-Small Cell Lung

Keywords

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Non-small cell lung cancer sunitinib erlotinib Phase 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

erlotinib

Intervention Type DRUG

plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity

sunitinib

Intervention Type DRUG

Sunitinib 37.5 mg daily by oral capsules in a continuous regimen

2

Group Type ACTIVE_COMPARATOR

erlotinib

Intervention Type DRUG

plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity

placebo

Intervention Type DRUG

Placebo daily by oral capsules in a continuous regimen

Interventions

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erlotinib

plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity

Intervention Type DRUG

sunitinib

Sunitinib 37.5 mg daily by oral capsules in a continuous regimen

Intervention Type DRUG

erlotinib

plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity

Intervention Type DRUG

placebo

Placebo daily by oral capsules in a continuous regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with locally advanced/metastatic non-small cell lung cancer
* Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria

* Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
* History of or known brain metastases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Florence, Alabama, United States

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Muscle Shoals, Alabama, United States

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Scottsdale, Arizona, United States

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Hot Springs, Arkansas, United States

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Antioch, California, United States

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Burbank, California, United States

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Downey, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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La Jolla, California, United States

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Montebello, California, United States

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Pleasant Hill, California, United States

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San Diego, California, United States

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San Leandro, California, United States

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Whittier, California, United States

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Fairfield, Connecticut, United States

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Brooksville, Florida, United States

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Cocoa Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Merritt Island, Florida, United States

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Rockledge, Florida, United States

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Titusville, Florida, United States

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Athens, Georgia, United States

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Aurora, Illinois, United States

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Goshen, Indiana, United States

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Indianapolis, Indiana, United States

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Council Bluffs, Iowa, United States

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Baton Rouge, Louisiana, United States

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Lafayette, Louisiana, United States

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Bethesda, Maryland, United States

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Ann Arbor, Michigan, United States

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Troy, Michigan, United States

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Columbus, Mississippi, United States

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Corinth, Mississippi, United States

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Tupelo, Mississippi, United States

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City of Saint Peters, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Jamaica, New York, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Lancaster, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Grapevine, Texas, United States

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Irving, Texas, United States

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Bountiful, Utah, United States

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Layton, Utah, United States

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Murray, Utah, United States

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Provo, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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West Valley City, Utah, United States

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Kennewick, Washington, United States

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Buenos Aires, Buenos Aires F.D., Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Córdoba, Córdoba Province, Argentina

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Buenos Aires, , Argentina

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Grimmenstein, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Brussels, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Barretos, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Kingston, Ontario, Canada

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Kingston, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Lévis, Quebec, Canada

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Québec, Quebec, Canada

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Rimouski, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Santiago, Chile, Chile

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Independencia, Santiago, RM, Chile

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Providencia, Santiago, RM, Chile

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Medellín, Antioquia, Colombia

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Medellín, Antioquia, Colombia

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České Budějovice, , Czechia

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Nová Ves pod Pleší, , Czechia

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Olomouc, , Czechia

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Ostrava-Poruba, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Pribram V, , Czechia

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Tábor, , Czechia

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Ústí nad Labem, , Czechia

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Herlev, , Denmark

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Hilleroed, , Denmark

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Koebenhavn OE, , Denmark

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Odense, , Denmark

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Bad Berka, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Ebensfeld, , Germany

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Essen, , Germany

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Gauting, , Germany

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Großhansdorf, , Germany

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Halle, , Germany

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Heidelberg, , Germany

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Homburg, , Germany

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Mainz, , Germany

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Tübingen, , Germany

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Wiesbaden, , Germany

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Heraklion, Crete, Greece

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Alexandroupoli, , Greece

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Athens, , Greece

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Kifisia, Athens, , Greece

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Kowloon, , Hong Kong

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Shatin, NT, , Hong Kong

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Tuenmen, , Hong Kong

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Budapest, , Hungary

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Deszk, , Hungary

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Gyula, , Hungary

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Mátraháza, , Hungary

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Székesfehérvár, , Hungary

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Zalaegerszeg-Pozva, , Hungary

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Catania, , Italy

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Grosseto, , Italy

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Mantova, , Italy

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Milan, , Italy

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Milan, , Italy

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Monza (MI), , Italy

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Novara, , Italy

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Orbassano (TO), , Italy

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Parma, , Italy

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Roma, , Italy

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Rozzano (MI), , Italy

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Enschede, Overijssel, Netherlands

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's-Hertogenbosch, , Netherlands

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Harderwijk, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Kristiansand, , Norway

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Oslo, , Norway

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Stavanger, , Norway

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Tromsø, , Norway

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Trondheim, , Norway

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Lodz, , Poland

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Opole, , Poland

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Otwock, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Zielona Góra, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Kvetnica Pri Poprade, , Slovakia

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Nitra-Zobor, , Slovakia

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Žilina, , Slovakia

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Palma de Mallorca, Balearic Islands, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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A Coruña, La Coruña, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

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Dos Hermanas, Sevilla, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Genolier, , Switzerland

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Gwei Shan Township, Taoyuan County, Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Pathumwan, Bangkok, Thailand

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Amphoe Mueang, Chiang Mai, Thailand

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Bangkok, , Thailand

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Bebington, Wirral, , United Kingdom

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Cambridge, , United Kingdom

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Derby, , United Kingdom

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Dundee, , United Kingdom

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Keighley, West Yorkshire, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Peterborough, , United Kingdom

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Rhyl, Denbigshire, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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Yeovil, Somerset, , United Kingdom

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Countries

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United States Argentina Austria Belgium Brazil Canada Chile Colombia Czechia Denmark Germany Greece Hong Kong Hungary Italy Netherlands Norway Poland Russia Slovakia South Korea Spain Switzerland Taiwan Thailand United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181087&StudyName=A%20Study%20In%20Patients%20With%20Non-Small%20Cell%20Lung%20Cancer%20To%20Test%20If%20Erlotinib%20Plus%20SU011248%20Is%20Better%20Than%20Erlotinib%20Alone

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

Other Identifiers

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SUN1087

Identifier Type: -

Identifier Source: secondary_id

A6181087

Identifier Type: -

Identifier Source: org_study_id