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LY293111

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Dec 21, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment195
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00069875A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung CancerPHASE2 COMPLETED 195 — — Sep 1, 2003Dec 1, 2005Dec 21, 200719 United States, Canada +4
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Study Endpoints
Primary Endpoints
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 Endpoints
time-to-event efficacy (overall survival, duration of response, time-to-response, time-to-treatment failure)
tumor response rate
toxicity rates
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GemcitabineDRUG -
LY293111DRUG -
cisplatinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

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 metastas...

Countries:United StatesCanadaGermanyIsraelNetherlandsSpain
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