|
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
|
