Table 1.

Key inclusion and exclusion criteria

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

*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

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.