Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)

Inclusion Criteria:

• Histologically or cytologically documented unresectable stage III NSCLC.
• Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization.
• Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of ≥ 50 Gy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible.
• Geographically accessible for ongoing follow-up, and committed to comply with the designated visits.
• An ECOG performance status of 0-1.
• A Platlet count > 140 x 10(9)/L; WBC > 2.5 x 10(9)/L and hemoglobin > 90 g/L.

Exclusion Criteria:

• Pre-Therapies:

  • Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy.
  • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization.
  • Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization.

• Disease Status:

  • Metastatic disease
  • Malignant pleural effusion at initial diagnosis and/or at study entry.
  • 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.
  • A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies.
  • Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed).
  • Known Hepatitis B and/or C.

• Physiological Functions:

  • Clinically significant hepatic dysfunction.
  • Clinically significant renal dysfunction.
  • Clinically significant cardiac disease.
  • Splenectomy.
  • Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response.

• Standard Safety:

  • Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator.
  • Known drug abuse/alcohol abuse.
  • Legal incapacity or limited legal capacity