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

Completed · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT00034268

Run by

Eli Lilly and Company

Starts

2002-03-01

Last updated by the study team

2006-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior chemotherapy or biologic therapy for NSCLC
• Central nervous system tumors
• Pregnant or breastfeeding

Where it is running

• Study site — Springdale, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Denver, Colorado, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Tucker, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Robbinsdale, Minnesota, United States
• Study site — Latham, New York, United States
• Study site — New York, New York, United States
• Study site — Arlington, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Abingdon, Virginia, United States
• Study site — Marshfield, Wisconsin, United States
• Study site — Mendoza, Mendoza Province, Argentina
• Study site — Ciudad de Buenos Aires, Argentina
• Study site — Brasschaat, Belgium
• Study site — Edegem, Belgium
• Study site — Liège, Belgium
• Study site — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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