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Table 1 Key inclusion and exclusion criteria

From: INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer

Inclusion criteria Histologically documented unresectable stage III NSCLC, with stage confirmed by imaging (CT and/or MRI and/or PET)
  Completion of chemoradiotherapy (concomitant or sequential) ≥ 4 weeks and ≤ 12 weeks prior to randomization, consisting of ≥ 2 cycles of platinum-based chemotherapy and a radiation dose of ≥ 50 Gy
  Stable disease or objective response after primary chemoradiotherapy according to RECIST [37] documented ≤ 4 weeks prior to randomization
  ECOG performance status of 0 or 1
  Platelet count ≥ 140 × 109/L; WBC ≥ 2.5 × 109/L; haemoglobin ≥ 90 g/L
  ≥ 18 years of age
Exclusion criteria  
Prior therapies Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy
  Immunotherapy ≤ 4 weeks prior to randomization
  Investigational systemic drugs ≤ 4 weeks prior to randomization
Disease status Metastatic disease
  Malignant pleural effusion
  Past or current history of neoplasm other than lung carcinoma*
  Autoimmune disease or recognized immunodeficiency
  Pre-existing medical conditions requiring chronic steroid or immunosuppressive drug therapy
  Signs and symptoms suggestive of, or family history of, transmissible spongiform encephalopathy
  Clinically significant active or chronic infectious hepatitis
  Hepatic dysfunction (ALT > 2.5 × ULN, AST > 2.5 × ULN or bilirubin ≥ 1.5 × ULN)
  Renal dysfunction (serum creatinine ≥ 1.5 × ULN)
  Clinically significant cardiac disease
  Splenectomy
  1. *Except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
  2. ALT: alanine aminotransferase; AST: aspartate aminotransferase; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; MRI: magnetic resonance imaging; NSCLC: non-small cell lung cancer; RECIST: Response Evaluation Criteria In Solid Tumors; ULN: upper limit of normal; WBC: white blood cell count.