Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
non-small cell lung cancer, Stage IIIB or IV non-small cell lung cancer (NSCLC)
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.
Interventions
DRUGLY900003
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
Argentina, Belgium, Chile, France, Germany, Hungary, India, Italy, Netherlands, Norway, Poland, Puerto Rico, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed