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LY900003

Phase 3

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 19, 2006

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034268A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung CancerPHASE3 COMPLETED -Mar 1, 2002 -Jul 19, 2006105 United States, Argentina +19
NCT00042679A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.PHASE2 COMPLETED -Jun 1, 2002 -Jul 19, 200611 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LY900003DRUG -
GemcitabineDRUG -
CarboplatinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites105

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 br...

Countries:United StatesArgentinaBelgiumChileFranceGermanyHungaryIndiaItalyNetherlandsNorwayPolandPuerto RicoRomaniaRussiaSouth AfricaSpainSwedenSwitzerlandTaiwanUnited Kingdom
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