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.