drugset / Trial / NCT00037713
Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG
Phase 3
Completed
515 enrolled
Eli Lilly and Company
EORTC Lung Cancer Cooperative Group · collabGroupe Francais De Pneumo-Cancerologie · collabIndependent centers (Australia, New Zealand, Europe, USA) · collabMemorial Sloan Kettering Cancer Center · collabMerck KGaA, Darmstadt, Germany · collabSchweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK) · collabSpanish Lung Cancer Group · collabUS Department of Veterans Affairs · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.
Timeline
- Start
- 1998-09
- Primary completion
- 2002-10
- Completion
- 2002-10
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG | Vaccine | — | Other |
| Subject | MITUMOMAB | Monoclonal antibody | 2.5 mg | Other |