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LY293111 with gemcitabine and cisplatin in advanced NSCLC
NCT00069875Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2003
- Countries
- 6
- Sponsor
- Eli Lilly and Company
- Drugs
- etalocib
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, randomised, double-blind trial of etalocib in non-small cell lung cancer (NSCLC) (3 arms), sponsored by Eli Lilly and Company. Primary endpoint: Progression-Free Survival. Started Sep 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
LY293111 200mg BID + Gem/Cis
LY293111 200 mg twice daily plus gemcitabine and cisplatin
LY293111 600mg BID + Gem/Cis
LY293111 600 mg twice daily plus gemcitabine and cisplatin
Placebo + Gem/Cis
Placebo twice daily plus gemcitabine and cisplatin
03
Who it enrols
Patients with Stage IIIB or IV NSCLC not amenable to surgery or radiation, with measurable disease and no prior systemic therapy for NSCLC.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Duration of Response
Time to Response
Time to Treatment Failure
Objective Response Rate
Toxicity Rates
Exposure-Response Relationship
Quality of Life
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