Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population (INSPIRE)

Inclusion Criteria:

• Histologically or cytologically documented unresectable stage III NSCLC.
• Documented stable disease or objective response, according to RECIST after primary chemo-radiotherapy (either sequential or concomitant) for unresectable stage III disease, within four weeks (28 days) prior to randomization.
• Receipt of concomitant or sequential chemo-radiotherapy, 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• A platelet count ≥ the lower limit of normal for the site or ≥ 100 x 10⁹/L (whichever is greater); WBC ≥ 2.5 x 10⁹/L and hemoglobin ≥ 90 g/L
• ≥18 years of age (or minimum age of legal consent consistent with local regulations, if minimum is > 18 years of age)

Exclusion Criteria:

Pre-Therapies*:

• Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy.
• Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GMCSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within four weeks (28 days) prior to randomization.
• Investigational systemic drugs (including off-label use of approved products) within four weeks (28 days) prior to randomization.

Disease Status:

• Metastatic disease
• Malignant pleural effusion at initial diagnosis and/or at trial 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 trial
• 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 active Hepatitis B infection and/or Hepatitis C infection
• Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such

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 breastfeeding women, women of childbearing potential, unless using effective contraception as determined by the investigator.
• Known drug abuse or alcohol abuse
• Participation in another clinical trial (excluding purely observational studies) within the past 28 days
• Requires concurrent treatment with a non-permitted drug
• Known hypersensitivity to any of the trial treatment ingredients
• Legal incapacity or limited legal capacity