The purpose of this study is to determine whether the cancer vaccine Stimuvax in addition to best supportive care is effective in prolonging the lives of patients with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

To Be Determined

• Biological: Stimuvax

  A single infusion (IV) of 300mg/m² (to a max.600mg) of Cyclophosphamide will be given three days before first Stimuvax vaccination.

  Subjects will then receive eight consecutive weekly subcutaneous vaccinations with 1,000µg of Stimuvax at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance vaccinations (1,000µg of Stimuvax) at 6-week intervals, commencing at week 13, until disease progression is documented.

• Biological: Placebo
  A single infusion (IV) of 0.9% Saline solution instead of Cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.

• 1: Experimental
  Following randomization, subjects in the investigational arm will receive, within 3 days of their treatment assignment, a single intravenous (I.V.) infusion of 300 mg/m2 (to a maximum of 600 mg) cyclophosphamide three days before the first L-BLP25 vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with L-BLP25 (primary treatment phase) followed by vaccinations with L-BLP25 at 6-week intervals, commencing at week 13 (maintenance treatment phase). Subjects will be discontinued from the study treatment upon documented disease progression (to be assessed according to Response Evaluation Criteria in Solid Tumors [RECIST])
  Intervention: Biological: Stimuvax
• 2: Placebo Comparator
  Following randomization, subjects in the placebo arm will receive, within 3 days of their treatment assignment, 0.9 percent (%) sodium chloride (saline) instead of cyclophosphamide and placebo instead of L-BLP25.
  Intervention: Biological: Placebo

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.

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 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 that in the opinion of the investigator could compromise the safety of the subject in this study.
  • 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