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

Lilly

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Small Cell Lung

Treatments: Biological: BEC2 Vaccine

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT00037713

SILVA EORTC 08971

Details and patient eligibility

About

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.

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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515 participants in 2 patient groups

1

No Intervention group

Description:

Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.

2

Experimental group

Description:

Treatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur: 1. intolerable toxicity precluding further treatment progression of disease 2. patient refusal 3. occurrence of pregnancy

Treatment:

Biological: BEC2 Vaccine