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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00034268 |
Purpose
The purposes of this study are to determine:
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: LY900003 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Springdale, Arkansas, United States | |
| Hot Springs, Arkansas, United States | |
| United States, California | |
| Los Angeles, California, United States | |
| Santa Rosa, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| Fort Collins, Colorado, United States | |
| United States, Delaware | |
| Wilmington, Delaware, United States | |
| United States, Georgia | |
| Tucker, Georgia, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| Detroit, Michigan, United States | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| Robbinsdale, Minnesota, United States | |
| United States, New York | |
| New York, New York, United States | |
| Latham, New York, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Arlington, Texas, United States | |
| United States, Virginia | |
| Abingdon, Virginia, United States | |
| United States, Wisconsin | |
| Marshfield, Wisconsin, United States | |
| Argentina | |
| Ciudad De Buenos Aires, Argentina | |
| Mendoza, Argentina | |
| Belgium | |
| Brasschaat, Belgium | |
| Oostende, Belgium | |
| Liege, Belgium | |
| Edegem, Belgium | |
| Merksem, Belgium | |
| Chile, Santiago | |
| Las Condes, Santiago, Chile | |
| France | |
| Pessac Cedex, France | |
| Tours Cedex, France | |
| Saint Herblain Cedex, France | |
| Nice Cedex 1, France | |
| Rouen Cedex, France | |
| Paris Cedex 20, France | |
| Brest, France | |
| Vandoeuvre Les Nancy Cedex, France | |
| Germany | |
| Augsburg, Germany | |
| Munchen, Germany | |
| Hofheim, Germany | |
| Koin, Germany | |
| Leipzig, Germany | |
| Hamburg, Germany | |
| Trier, Germany | |
| Freiburg, Germany | |
| Ulm, Germany | |
| Berlin, Germany | |
| Heidelberg, Germany | |
| Grobhansdorf, Germany | |
| Neustadt/Suedharz, Germany | |
| Germany, Hessen | |
| Frankfurt, Hessen, Germany | |
| Hungary | |
| Budapest, Hungary | |
| India | |
| New Dehli, India | |
| India, Karnataka | |
| Bangalore, Karnataka, India | |
| India, Maharashtra | |
| Pune, Maharashtra, India | |
| Mumbai, Maharashtra, India | |
| India, Punjab | |
| Ludhiana, Punjab, India | |
| Italy | |
| Pisa, Italy | |
| Ravenna, Italy | |
| Perugia, Italy | |
| Roma, Italy | |
| Italy, Milano | |
| Rozzano, Milano, Italy | |
| Netherlands | |
| Nieuwegien, Netherlands | |
| Den Bosch, Netherlands | |
| Arnhem, Netherlands | |
| Groningen, Netherlands | |
| Amsterdam, Netherlands | |
| Zwolle, Netherlands | |
| Norway | |
| Oslo, Norway | |
| Poland | |
| Wroclaw, Poland | |
| Krakow-Nowa Huta, Poland | |
| Warszawa, Poland | |
| Poland, Mazowieckie | |
| Otwock, Mazowieckie, Poland | |
| Puerto Rico | |
| Bayamon, Puerto Rico | |
| Ponce, Puerto Rico | |
| Romania, Cluj | |
| Cluj Napoca, Cluj, Romania | |
| Russian Federation | |
| Moscow, Russian Federation | |
| South Africa | |
| Tygerberg, South Africa | |
| Durban, South Africa | |
| Parklands, South Africa | |
| South Africa, Durban | |
| Overport, Durban, South Africa | |
| South Africa, Gauteng | |
| Arcadia, Gauteng, South Africa | |
| Spain | |
| Alicante, Spain | |
| Barcelona, Spain | |
| Zaragoza, Spain | |
| Palma De Mallorca, Spain | |
| Madrid, Spain | |
| Spain, Asturias | |
| Oviedo, Asturias, Spain | |
| Spain, Barcelona | |
| Sabadell, Barcelona, Spain | |
| Badalona, Barcelona, Spain | |
| Spain, Valenica | |
| Valencia, Valenica, Spain | |
| Spain, Vizcaya | |
| Barakaldo, Vizcaya, Spain | |
| Sweden | |
| Linkoping, Sweden | |
| Stockhlom, Sweden | |
| Lund, Sweden | |
| Switzerland | |
| Zurich, Switzerland | |
| Taiwan | |
| Taipei, Taiwan | |
| Taiwan, Kuei-Shan | |
| Tao-Yuan, Kuei-Shan, Taiwan | |
| Taiwan, Taiwan, Province of China | |
| Taichung, Taiwan, Province of China, Taiwan | |
| United Kingdom, East Yorkshire | |
| Hull, East Yorkshire, United Kingdom | |
| United Kingdom, Greater London | |
| London, Greater London, United Kingdom | |
| United Kingdom, Hampshire | |
| Southampton, Hampshire, United Kingdom | |
| United Kingdom, Nottinghamshire | |
| Nottingham, Nottinghamshire, United Kingdom | |
| United Kingdom, Scotland | |
| Glasgow, Scotland, United Kingdom | |
| United Kingdom, South Glamorgan | |
| Cardiff, South Glamorgan, United Kingdom | |
| United Kingdom, Tyneside | |
| Newcastle-Upon-Tyne, Tyneside, United Kingdom | |
More Information
| Study ID Numbers: | 6428, H7X-MC-JVAA |
| Study First Received: | April 24, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034268 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
non-small cell lung cancer Stage IIIB or IV non-small cell lung cancer (NSCLC) |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
