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 |