Back to resultsA Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LY900003
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring non-small cell lung cancer, Stage IIIB or IV non-small cell lung cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Prior chemotherapy or biologic therapy for NSCLC Central nervous system tumors Pregnant or breastfeeding
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034268
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purposes of this study are to determine:
If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
non-small cell lung cancer, Stage IIIB or IV non-small cell lung cancer (NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LY900003
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Prior chemotherapy or biologic therapy for NSCLC
Central nervous system tumors
Pregnant or breastfeeding
Facility Information:
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Springdale
State/Province
Arkansas
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Fort Collins
State/Province
Colorado
Country
United States
City
Wilmington
State/Province
Delaware
Country
United States
City
Tucker
State/Province
Georgia
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Robbinsdale
State/Province
Minnesota
Country
United States
City
Latham
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Abingdon
State/Province
Virginia
Country
United States
City
Marshfield
State/Province
Wisconsin
Country
United States
City
Ciudad De Buenos Aires
Country
Argentina
City
Mendoza
Country
Argentina
City
Brasschaat
Country
Belgium
City
Edegem
Country
Belgium
City
Liege
Country
Belgium
City
Merksem
Country
Belgium
City
Oostende
Country
Belgium
City
Las Condes
State/Province
Santiago
Country
Chile
City
Brest
Country
France
City
Nice Cedex 1
Country
France
City
Paris Cedex 20
Country
France
City
Pessac Cedex
Country
France
City
Rouen Cedex
Country
France
City
Saint Herblain Cedex
Country
France
City
Tours Cedex
Country
France
City
Vandoeuvre Les Nancy Cedex
Country
France
City
Frankfurt
State/Province
Hessen
Country
Germany
City
Augsburg
Country
Germany
City
Berlin
Country
Germany
City
Freiburg
Country
Germany
City
Grobhansdorf
Country
Germany
City
Hamburg
Country
Germany
City
Heidelberg
Country
Germany
City
Hofheim
Country
Germany
City
Koin
Country
Germany
City
Leipzig
Country
Germany
City
Munchen
Country
Germany
City
Neustadt/Suedharz
Country
Germany
City
Trier
Country
Germany
City
Ulm
Country
Germany
City
Budapest
Country
Hungary
City
Bangalore
State/Province
Karnataka
Country
India
City
Mumbai
State/Province
Maharashtra
Country
India
City
Pune
State/Province
Maharashtra
Country
India
City
Ludhiana
State/Province
Punjab
Country
India
City
New Dehli
Country
India
City
Rozzano
State/Province
Milano
Country
Italy
City
Perugia
Country
Italy
City
Pisa
Country
Italy
City
Ravenna
Country
Italy
City
Roma
Country
Italy
City
Amsterdam
Country
Netherlands
City
Arnhem
Country
Netherlands
City
Den Bosch
Country
Netherlands
City
Groningen
Country
Netherlands
City
Nieuwegien
Country
Netherlands
City
Zwolle
Country
Netherlands
City
Oslo
Country
Norway
City
Otwock
State/Province
Mazowieckie
Country
Poland
City
Krakow-Nowa Huta
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Bayamon
Country
Puerto Rico
City
Ponce
Country
Puerto Rico
City
Cluj Napoca
State/Province
Cluj
Country
Romania
City
Moscow
Country
Russian Federation
City
Overport
State/Province
Durban
Country
South Africa
City
Arcadia
State/Province
Gauteng
Country
South Africa
City
Durban
Country
South Africa
City
Parklands
Country
South Africa
City
Tygerberg
Country
South Africa
City
Oviedo
State/Province
Asturias
Country
Spain
City
Badalona
State/Province
Barcelona
Country
Spain
City
Sabadell
State/Province
Barcelona
Country
Spain
City
Valencia
State/Province
Valenica
Country
Spain
City
Barakaldo
State/Province
Vizcaya
Country
Spain
City
Alicante
Country
Spain
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Palma De Mallorca
Country
Spain
City
Zaragoza
Country
Spain
City
Linkoping
Country
Sweden
City
Lund
Country
Sweden
City
Stockhlom
Country
Sweden
City
Zurich
Country
Switzerland
City
Tao-Yuan
State/Province
Kuei-Shan
Country
Taiwan
City
Taichung
State/Province
Taiwan, Province of China
Country
Taiwan
City
Taipei
Country
Taiwan
City
Hull
State/Province
East Yorkshire
Country
United Kingdom
City
London
State/Province
Greater London
Country
United Kingdom
City
Southampton
State/Province
Hampshire
Country
United Kingdom
City
Nottingham
State/Province
Nottinghamshire
Country
United Kingdom
City
Glasgow
State/Province
Scotland
Country
United Kingdom
City
Cardiff
State/Province
South Glamorgan
Country
United Kingdom
City
Newcastle-Upon-Tyne
State/Province
Tyneside
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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