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BEC2 Vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | NO_INTERVENTION | Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease. |
| 2 | EXPERIMENTAL | Treatment 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 |
| Name | Type | Description |
|---|---|---|
| BEC2 Vaccine | BIOLOGICAL | 5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 \& 10. |
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...
The BEC2 vaccine was studied as an adjuvant treatment for limited disease small cell lung cancer, a form of lung cancer that has not spread beyond the chest. It was given after standard therapy to patients with this condition in a Phase 3 clinical trial.
The BEC2 vaccine was developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the clinical trial that evaluated the vaccine in small cell lung cancer.
The BEC2 vaccine reached Phase 3 clinical development for limited disease small cell lung cancer. It is an investigational vaccine and has not been approved by the FDA for any indication. The Phase 3 trial has been completed.
The BEC2 vaccine was evaluated in one Phase 3 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 patients and has been completed.
The Phase 3 trial NCT00037713 was a randomized study that compared adjuvant BEC2 plus BCG against no treatment in 515 patients with limited disease small cell lung cancer. It was not double blinded, and participants were 18 years or older.