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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
515
5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 \& 10.
Overall survival
Time frame: 6 monthly basis until progression of disease
Progression-free survival
Time frame: 6 monthly basis until progression of disease
Safety
Time frame: 6 monthly basis until progression of disease
Quality of Life
Time frame: 6 monthly basis until progression of disease
Health Economics Aspects
Time frame: 6 monthly basis until progression of disease
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.