Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine and cisplatin in patients with non-small cell lung cancer.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-Small Cell Lung Cancer, Stage IIIB or IV that is not amenable to either surgery of curative intent or radiation therapy * Tumor that can be measured by x-ray or scan * Adequate organ function
Exclusion criteria
* Inability to swallow capsules * Documented brain metastases * Prior chemotherapy or biological therapy for this disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if progression-free survival in patients with Stage IIIB or IV NSCLC receiving gemcitabine and cisplatin can be improved by adding 200 or 600 mg BID of LY293111 as compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| time-to-event efficacy (overall survival, duration of response, time-to-response, time-to-treatment failure) | — |
| tumor response rate | — |
| toxicity rates | — |
| exposure-response relationship | — |
| quality of life | — |
Countries
Canada, Germany, Israel, Netherlands, Spain, United States
Outcome results
None listed