Table 1

Inclusion criteria and exclusion criteria

Inclusion criteriaExclusion criteria
Aged 18–75 years.Histologically or cytologically confirmed mixed SCLC.
Histologically or cytologically confirmed SCLC.Suitable for surgery.
Limited stage SCLC.Patients with other active malignancies within 5 years or at the same time. Localised tumours that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast cancer in situ, are acceptable.
Score of Eastern Cooperative Oncology Group performance status (ECOG PS) being 0 or 1.Patients with pleural, pericardial effusions or ascites requiring clinical intervention.
Without previous anti-tumour treatment historyUncontrolled or symptomatic hypercalcaemia (>1.5 mmol/L ionised calcium or calcium >12 mg/dL or corrected serum calcium>ULN).
Without serious abnormalities in haematopoietic function or cardiac, hepatic, or renal function or immunodeficiency.Patients with peripheral neuropathy≥grade 2 by CTCAE.
Expected survival of at least 3 monthsPatients with HIV, Hepatitis B or C infection.
Voluntarily participate in this clinical study and signed the informed consent form.Patients with active pulmonary tuberculosis, previous and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severely impaired pulmonary function as judged by the investigator.
Subjects with known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to be enrolled.
  • CTCAE, Common Terminology Criteria for Adverse Events; SCLC, small-cell lung cancer; ULN, Upper Limit of Normal.