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 - Tabular View

Tracking Information
First Received Date ^ICMJE	April 24, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung
Intervention ^ICMJE	Drug: LY900003
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Belgium, Chile, France, Germany, Hungary, India, Italy, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00034268
Responsible Party
Study ID Numbers ^ICMJE	6428, H7X-MC-JVAA
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP