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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

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

LY900003 · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT00034268A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell Lung
COMPLETED- Analytics
PHASE3COMPLETED
A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell LungUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
LY900003DRUG -
GemcitabineDRUG -
CarboplatinDRUG -
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about LY900003

What is LY900003 used for in non-small cell lung cancer?

LY900003 is an investigational small molecule being studied for the treatment of carcinoma, non-small-cell lung cancer. It was evaluated in clinical trials as a combination therapy with gemcitabine and cisplatin or carboplatin in patients with advanced, previously untreated non-small cell lung cancer. The drug is not approved and remains in clinical development.

What does LY900003 target?

LY900003 is an antisense nucleotide to PKC-alpha, meaning it is designed to target protein kinase C-alpha. This mechanism was the basis for its evaluation in non-small cell lung cancer clinical trials, where it was combined with standard chemotherapy regimens.

Who is developing LY900003?

LY900003 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The drug was studied in clinical trials for non-small cell lung cancer, though it is not currently in active development based on completed trials.

What phase is LY900003 in?

LY900003 has completed Phase 2 and Phase 3 clinical trials for non-small cell lung cancer. The Phase 3 trial, NCT00034268, evaluated LY900003 plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with advanced, previously untreated disease. The drug is investigational and not FDA approved.

What clinical trials is LY900003 in?

LY900003 has been studied in two completed clinical trials. NCT00034268 was a Phase 3 trial combining LY900003 with gemcitabine and cisplatin for advanced non-small cell lung cancer. NCT00042679 was a Phase 2 trial combining LY900003 with gemcitabine and carboplatin for the same condition. Both trials are completed.

Is LY900003 the same as ISIS 3521?

Yes, LY900003 is also known as ISIS 3521, as indicated in the Phase 2 trial title. The drug is an antisense nucleotide to PKC-alpha and was evaluated under both names in clinical trials for non-small cell lung cancer.