A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease
Inclusion Criteria:
- Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement
must be confirmed by biopsy
- Stable disease or clinical response after primary therapy of chemo-radiation
treatment for unresectable stage III disease
- Primary therapy should be a minimum of 2 cycles of Platinum-based first-line
chemotherapy, given concurrent with thoracic radiation. The combined modality should
consist of either:
- induction (2 cycles) chemotherapy followed by concurrent chemo/RT; or
- concurrent chemo/RT followed by 2 cycles of consolidation chemotherapy; or
- concurrent chemo/RT alone
- A minimum radiation dose of ≥6,000cGy should be administered. Patients must have
completed the primary therapy at least 4 weeks and no later than 6 months prior to
study entry
- ECOG performance status of ≤1
- Ability to understand and willingness to sign a written informed consent
Exclusion Criteria:
- Undergone lung cancer specific therapy (including surgery) prior to primary chemo/RT
- Received immunotherapy within 4 weeks prior to study entry
- Received systemic immunosuppressive drugs within 4 weeks prior to study entry
- Received investigational systemic drugs within 4 weeks prior to study entry
- Brain metastases
- Pleural effusion, unless cytologically confirmed to be non-malignant
- Past or current history of neoplasm other than lung carcinoma, except for curatively
treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer
curatively treated and with no evidence of disease for at least 5 years
- Autoimmune disease or immunodeficiency
- Clinically significant hepatic, renal or cardiac dysfunction
- Clinically significant active infection
- Pregnant or lactating, women of childbearing potential, unless using effective
contraception as determined by the investigator