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

NCT00034268 — Phase 3, Completed, Eli Lilly and Company

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RegistryNCT00034268
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
SponsorEli Lilly and Company (Industry)
ConditionsCarcinoma, Non-Small-Cell Lung
InterventionsLY900003 (Drug)
Datesstart 2002-03-01, first posted 2002-04-25, last updated 2006-07-19
Locations105 sites in United States, Argentina, Belgium, Chile, France, Germany, Hungary, India and 13 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Carcinoma, Non-Small-Cell Lung All trials of LY900003

-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.

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.

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+Arms and interventions

  • LY900003 (Drug)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (105)

FacilityCityCountryStatus
Hot Springs, ArkansasUnited States
Springdale, ArkansasUnited States
Los Angeles, CaliforniaUnited States
Santa Rosa, CaliforniaUnited States
Denver, ColoradoUnited States
Fort Collins, ColoradoUnited States
Wilmington, DelawareUnited States
Tucker, GeorgiaUnited States
Indianapolis, IndianaUnited States
New Orleans, LouisianaUnited States
Baltimore, MarylandUnited States
Detroit, MichiganUnited States
Minneapolis, MinnesotaUnited States
Robbinsdale, MinnesotaUnited States
Latham, New YorkUnited States
New York, New YorkUnited States
Arlington, TexasUnited States
Dallas, TexasUnited States
Abingdon, VirginiaUnited States
Marshfield, WisconsinUnited States
Mendoza, Mendoza ProvinceArgentina
Ciudad de Buenos AiresArgentina
BrasschaatBelgium
EdegemBelgium
LiègeBelgium
MerksemBelgium
OstendBelgium
Las Condes, Santiago MetropolitanChile
BrestFrance
NiceFrance
ParisFrance
PessacFrance
RouenFrance
Saint-HerblainFrance
ToursFrance
Vandœuvre-lès-NancyFrance
Frankfurt am Main, HesseGermany
AugsburgGermany
BerlinGermany
Freiburg im BreisgauGermany
GrobhansdorfGermany
HamburgGermany
HeidelbergGermany
HofheimGermany
KoinGermany
LeipzigGermany
MünchenGermany
Neustadt/SuedharzGermany
TrierGermany
UlmGermany
BudapestHungary
Bangalore, KarnatakaIndia
Mumbai, MaharashtraIndia
Pune, MaharashtraIndia
Ludhiana, PunjabIndia
New DehliIndia
Rozzano, MilanoItaly
PerugiaItaly
PisaItaly
RavennaItaly
RomaItaly
's-HertogenboschNetherlands
AmsterdamNetherlands
ArnhemNetherlands
GroningenNetherlands
NieuwegienNetherlands
ZwolleNetherlands
OsloNorway
Otwock, Masovian VoivodeshipPoland
Warsaw, WarszawaPoland
Krakow-Nowa HutaPoland
WroclawPoland
BayamónPuerto Rico
PoncePuerto Rico
Cluj-Napoca, ClujRomania
MoscowRussia
Overport, DurbanSouth Africa
Arcadia, GautengSouth Africa
DurbanSouth Africa
ParklandsSouth Africa
TygerbergSouth Africa
Alicante, AlicanteSpain
Badalona, BarcelonaSpain
Barcelona, BarcelonaSpain
Sabadell, BarcelonaSpain
Madrid, MadridSpain
Palma de Mallorca, Palma de MallorcaSpain
Oviedo, Principality of AsturiasSpain
Valencia, ValenicaSpain
Barakaldo, VizcayaSpain
Zaragoza, ZaragozaSpain
LinköpingSweden
LundSweden
StockhlomSweden
ZurichSwitzerland
Taoyuan, Kuei-ShanTaiwan
Taichung, Taiwan, Province of ChinaTaiwan
TaipeiTaiwan
Hull, East YorkshireUnited Kingdom
London, Greater LondonUnited Kingdom

5 more sites not listed.