Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

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 Written informed Consent Exclusion Criteria: Prior surgical treatment for SCLC History of tuberculosis NCIC CTG grade 3 local skin toxicity reaction (ulceration) to > IU PPD test > 5 IU HIV positive Splenectomy or spleen radiation therapy in medical history Prior therapy to proteins of murine origin Any second line therapy for SCLC Investigational agent or immune therapy within 4 weeks prior to study randomization Severe active infections Active infections requiring systemic antibiotics, antiviral, or antifungal treatments Serious unstable chronic illness The use of systemic anti-histamines, NSAID or systemic corticosteroids Any previous malignancy except adequately treated CIS of the cervix or non melanoma skin cancer or if previous malignancy was more than 5 years prior and there are no signs of recurrence Pregnancy or breast feeding or absence of adequate contraception for fertile patients Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.