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