NCT00034268

Brief Summary

The purposes of this study are to determine:

  1. 1.If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
  2. 2.The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
  3. 3.Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Geographic Reach
21 countries

105 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2002

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

April 24, 2002

Last Update Submit

July 18, 2006

Conditions

Keywords

non-small cell lung cancerStage IIIB or IV non-small cell lung cancer (NSCLC)

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage IIIB or IV non-small lung cancer
  • Able to visit the doctor's office
  • At least 18 years of age
  • Adequate kidney, adrenal, and liver function

You may not qualify if:

  • Prior chemotherapy or biologic therapy for NSCLC
  • Central nervous system tumors
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (105)

Unknown Facility

Hot Springs, Arkansas, United States

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Springdale, Arkansas, United States

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Los Angeles, California, United States

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Santa Rosa, California, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Wilmington, Delaware, United States

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Tucker, Georgia, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Latham, New York, United States

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New York, New York, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Abingdon, Virginia, United States

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Marshfield, Wisconsin, United States

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Mendoza, Mendoza Province, Argentina

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Ciudad de Buenos Aires, Argentina

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Brasschaat, Belgium

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Edegem, Belgium

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Liège, Belgium

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Merksem, Belgium

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Ostend, Belgium

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Las Condes, Santiago Metropolitan, Chile

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Brest, France

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Nice, France

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Paris, France

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Pessac, France

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Rouen, France

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Saint-Herblain, France

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Tours, France

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Vandœuvre-lès-Nancy, France

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Frankfurt am Main, Hesse, Germany

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Augsburg, Germany

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Berlin, Germany

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Freiburg im Breisgau, Germany

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Grobhansdorf, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Hofheim, Germany

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Koin, Germany

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Leipzig, Germany

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München, Germany

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Neustadt/Suedharz, Germany

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Trier, Germany

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Ulm, Germany

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Budapest, Hungary

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Bangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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New Dehli, India

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Rozzano, Milano, Italy

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Perugia, Italy

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Pisa, Italy

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Ravenna, Italy

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Roma, Italy

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's-Hertogenbosch, Netherlands

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Amsterdam, Netherlands

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Arnhem, Netherlands

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Groningen, Netherlands

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Nieuwegien, Netherlands

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Zwolle, Netherlands

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Oslo, Norway

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Otwock, Masovian Voivodeship, Poland

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Warsaw, Warszawa, Poland

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Krakow-Nowa Huta, Poland

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Wroclaw, Poland

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Bayamón, Puerto Rico

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Ponce, Puerto Rico

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Cluj-Napoca, Cluj, Romania

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Moscow, Russia

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Overport, Durban, South Africa

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Arcadia, Gauteng, South Africa

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Durban, South Africa

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Parklands, South Africa

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Tygerberg, South Africa

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Alicante, Alicante, Spain

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Madrid, Madrid, Spain

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Palma de Mallorca, Palma de Mallorca, Spain

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Oviedo, Principality of Asturias, Spain

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Valencia, Valenica, Spain

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Barakaldo, Vizcaya, Spain

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Zaragoza, Zaragoza, Spain

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Linköping, Sweden

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Lund, Sweden

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Stockhlom, Sweden

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Zurich, Switzerland

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Taoyuan District, Kuei-Shan, Taiwan

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Taichung, Taiwan, Province of China, Taiwan

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Taipei, Taiwan

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Hull, East Yorkshire, United Kingdom

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London, Greater London, United Kingdom

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Southampton, Hampshire, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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Glasgow, Scotland, United Kingdom

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Cardiff, South Glamorgan, United Kingdom

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Newcastle upon Tyne, Tyneside, United Kingdom

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ISIS 3521

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2002

First Posted

April 25, 2002

Study Start

March 1, 2002

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations