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

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

Patrocinadores

Patrocinador principal: Eli Lilly and Company

Fuente Eli Lilly and Company
Resumen breve

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.

Estado general Completed
Fecha de inicio March 2002
Fase Phase 3
Tipo de estudio Interventional
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: LY900003

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
| Hot Springs, Arkansas, United States
| Springdale, Arkansas, United States
| Los Angeles, California, United States
| Santa Rosa, California, United States
| Denver, Colorado, United States
| Fort Collins, Colorado, United States
| Wilmington, Delaware, United States
| Tucker, Georgia, United States
| Indianapolis, Indiana, United States
| New Orleans, Louisiana, United States
| Baltimore, Maryland, United States
| Detroit, Michigan, United States
| Minneapolis, Minnesota, United States
| Robbinsdale, Minnesota, United States
| Latham, New York, United States
| New York, New York, United States
| Arlington, Texas, United States
| Dallas, Texas, United States
| Abingdon, Virginia, United States
| Marshfield, Wisconsin, United States
| Ciudad De Buenos Aires, Argentina
| Mendoza, Argentina
| Brasschaat, Belgium
| Edegem, Belgium
| Liege, Belgium
| Merksem, Belgium
| Oostende, Belgium
| Las Condes, Santiago, Chile
| Brest, France
| Nice Cedex 1, France
| Paris Cedex 20, France
| Pessac Cedex, France
| Rouen Cedex, France
| Saint Herblain Cedex, France
| Tours Cedex, France
| Vandoeuvre Les Nancy Cedex, France
| Frankfurt, Hessen, Germany
| Augsburg, Germany
| Berlin, Germany
| Freiburg, Germany
| Grobhansdorf, Germany
| Hamburg, Germany
| Heidelberg, Germany
| Hofheim, Germany
| Koin, Germany
| Leipzig, Germany
| Munchen, Germany
| Neustadt/Suedharz, Germany
| Trier, Germany
| Ulm, Germany
| Budapest, Hungary
| Bangalore, Karnataka, India
| Mumbai, Maharashtra, India
| Pune, Maharashtra, India
| Ludhiana, Punjab, India
| New Dehli, India
| Rozzano, Milano, Italy
| Perugia, Italy
| Pisa, Italy
| Ravenna, Italy
| Roma, Italy
| Amsterdam, Netherlands
| Arnhem, Netherlands
| Den Bosch, Netherlands
| Groningen, Netherlands
| Nieuwegien, Netherlands
| Zwolle, Netherlands
| Oslo, Norway
| Otwock, Mazowieckie, Poland
| Krakow-Nowa Huta, Poland
| Warszawa, Poland
| Wroclaw, Poland
| Bayamon, Puerto Rico
| Ponce, Puerto Rico
| Cluj Napoca, Cluj, Romania
| Moscow, Russian Federation
| Overport, Durban, South Africa
| Arcadia, Gauteng, South Africa
| Durban, South Africa
| Parklands, South Africa
| Tygerberg, South Africa
| Oviedo, Asturias, Spain
| Badalona, Barcelona, Spain
| Sabadell, Barcelona, Spain
| Valencia, Valenica, Spain
| Barakaldo, Vizcaya, Spain
| Alicante, Spain
| Barcelona, Spain
| Madrid, Spain
| Palma De Mallorca, Spain
| Zaragoza, Spain
| Linkoping, Sweden
| Lund, Sweden
| Stockhlom, Sweden
| Zurich, Switzerland
| Tao-Yuan, Kuei-Shan, Taiwan
| Taichung, Taiwan, Province of China, Taiwan
| Taipei, Taiwan
| Hull, East Yorkshire, United Kingdom
| London, Greater London, United Kingdom
| Southampton, Hampshire, United Kingdom
| Nottingham, Nottinghamshire, United Kingdom
| Glasgow, Scotland, United Kingdom
| Cardiff, South Glamorgan, United Kingdom
| Newcastle-Upon-Tyne, Tyneside, United Kingdom
Ubicacion Paises

Argentina

Belgium

Chile

France

Germany

Hungary

India

Italy

Netherlands

Norway

Poland

Puerto Rico

Romania

Russian Federation

South Africa

Spain

Sweden

Switzerland

Taiwan

United Kingdom

United States

Fecha de verificación

July 2006

Palabras clave
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov