Clinical trial NCT00034268: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: non-small cell lung cancer
Stage IIIB or IV non-small cell lung cancer (NSCLC)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-04-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Wilmington
country: United States
state: Delaware
city: Tucker
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Robbinsdale
country: United States
state: Minnesota
city: Latham
country: United States
state: New York
city: New York
country: United States
state: New York
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Abingdon
country: United States
state: Virginia
city: Marshfield
country: United States
state: Wisconsin
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
country: Chile
state: Santiago
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
country: Germany
state: Hessen
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
country: India
state: Karnataka
city: Mumbai
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Ludhiana
country: India
state: Punjab
city: New Dehli
country: India
city: Rozzano
country: Italy
state: Milano
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
country: Poland
state: Mazowieckie
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
country: Romania
state: Cluj
city: Moscow
country: Russian Federation
city: Overport
country: South Africa
state: Durban
city: Arcadia
country: South Africa
state: Gauteng
city: Durban
country: South Africa
city: Parklands
country: South Africa
city: Tygerberg
country: South Africa
city: Oviedo
country: Spain
state: Asturias
city: Badalona
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Valencia
country: Spain
state: Valenica
city: Barakaldo
country: Spain
state: Vizcaya
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
country: Taiwan
state: Kuei-Shan
city: Taichung
country: Taiwan
state: Taiwan, Province of China
city: Taipei
country: Taiwan
city: Hull
country: United Kingdom
state: East Yorkshire
city: London
country: United Kingdom
state: Greater London
city: Southampton
country: United Kingdom
state: Hampshire
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Glasgow
country: United Kingdom
state: Scotland
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Newcastle-Upon-Tyne
country: United Kingdom
state: Tyneside
Study officials:
References: