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BEC2 Vaccine

Phase 3

Carcinoma, Small Cell Lung | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Apr 8, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment515

FDA Designations

No designations recorded

Clinical trial landscape

BEC2 Vaccine · 1 trial · 1 indication

Phase 3 1
NCT00037713Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCGCarcinoma, Small Cell Lung
COMPLETED515 Analytics
PHASE3COMPLETED
Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG
Carcinoma, Small Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival
6 monthly basis until progression of disease

Secondary Endpoints

Progression-free survival
6 monthly basis until progression of disease
Safety
6 monthly basis until progression of disease
Quality of Life
6 monthly basis until progression of disease
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1NO_INTERVENTIONBest supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.
2EXPERIMENTALTreatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur: 1. intolerable toxicity precluding further treatment progression of disease 2. patient refusal 3. occurrence of pregnancy

Interventions

NameTypeDescription
BEC2 VaccineBIOLOGICAL5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 \& 10.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Histo-cytologically proven SCLC * Limited disease at diagnosis * Age greater than or equal to 18 * Patients with a clinical response of CR or PR to first line combined modality therapy * KPS greater than or equal to 60 * Adequate bone marrow, liver and heart functions * Writte...

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Frequently asked questions about BEC2 Vaccine

What is BEC2 Vaccine used for?

BEC2 Vaccine is an investigational monoclonal antibody being studied for the treatment of small cell lung cancer, specifically in patients with limited disease. It is administered as an adjuvant vaccine in combination with BCG. The drug is not approved and remains in clinical development.

Who makes BEC2 Vaccine?

BEC2 Vaccine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research on this investigational therapy for small cell lung cancer.

What phase is BEC2 Vaccine in?

BEC2 Vaccine is in Phase 3 clinical development. It has completed a Phase 3 trial in patients with limited disease small cell lung cancer. As an investigational drug, it is not yet approved by regulatory authorities and remains under study.

What clinical trials is BEC2 Vaccine in?

BEC2 Vaccine has one completed Phase 3 clinical trial, NCT00037713, titled "Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG." The trial enrolled 515 participants and was not double-blinded.

Is BEC2 Vaccine the same as any other drug?

BEC2 Vaccine is also known as BEC2. It is a monoclonal antibody being investigated as an adjuvant vaccine for small cell lung cancer. No other alternative names have been reported for this investigational drug.