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

NCT ID: NCT00034268

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Brief Summary

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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.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.

LY900003 may not add any benefit to gemcitabine plus cisplatin.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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LY900003

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Prior chemotherapy or biologic therapy for NSCLC
2. Central nervous system tumors
3. Pregnant or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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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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Countries

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United States Argentina Belgium Chile France Germany Hungary India Italy Netherlands Norway Poland Puerto Rico Romania Russia South Africa Spain Sweden Switzerland Taiwan United Kingdom

Other Identifiers

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H7X-MC-JVAA

Identifier Type: -

Identifier Source: secondary_id

6428

Identifier Type: -

Identifier Source: org_study_id