A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC

Inclusion Criteria11

• Patients should voluntarily join this study and sign the informed consent form
• NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc)
• Patients with IIIB - IVA oligometastatic NSCLC : (a) IIIB - IIIC stage (T1-4N2-3): patients are not suitable or refuse to receive upfront surgical resection or radiotherapy; (b) oligometastatic stage IV (T1-3N0-2): radical resection/radiotherapy is feasible for metastatic lesions (the number of metastases being up to 3, and the maximum diameter of metastases being up to 2cm)
• After evaluation by MDT, upfront surgical resection is not the preferred treatment, but after induction systemic treatments, radical resection of the primary tumor is feasible, and radical resection/radiotherapy is feasible for extrathoracic metastases (if any)
• Age from 18 to 75 years old, both male and female
• ECOG score 0-1
• According to the RECIST v1.1 , patients should have at least one measurable lesion
• For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy
• According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy
• The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109/L； Platelets ≥ 100 × 109/L； Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1 × ULN； Serum bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 3 × ULN； International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN； Serum creatinine ≤ 1.5 × ULN
• Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period