A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00069875
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
🇨🇦Montreal, Quebec, Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇪🇸Madrid, Spain