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

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.