A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
2 other identifiers
interventional
N/A
21 countries
105
Brief Summary
The purposes of this study are to determine:
- 1.If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
- 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.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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 24, 2002
CompletedFirst Posted
Study publicly available on registry
April 25, 2002
CompletedJuly 19, 2006
July 1, 2006
April 24, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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