A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC

Inclusion criteria

Only the patients meeting all the following criteria can be eligible to participate in the trial:

• Histologically and/or cytologically confirmed stage IV non-small cell lung cancer and ALK fusion
• At least one measurable lesion 3 No history of any systemic anti-tumor therapy.

• Agreement on providing formalin fixed tumor tissue specimen or fresh biopsy tissue from tumor lesions after diagnosis of metastasis 6. Age of 18-75 years 7. ECOG Scores 0-1; 8. Expected survival ≥ 3 months;

Exclusion criteria

• Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;
• Histologically or cytopathologically confirmed combination with small cell lung cancer component or sarcomatoid lesion;
• Current participation in and receiving other study treatment, or participation in treatment of one study drug within 4 weeks prior to administration of JS001;
• Previous use of systematic chemotherapy for advanced NSCLC; targeted therapy for advanced NSCLC
• Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cells synergetic stimulation or checkpoint pathway, such as IDO, IL-2R, GITR);
• Chest (lung) radiotherapy > 30 Gy within 6 months prior to the start of study treatment.
• Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening;
• Known active central nervous system (CNS) metastasis and/or cancerous meningitis;
• Spinal cord compression for which operation and/or radical radiotherapy has not been given, or no clinical evidence of stable disease for ≥4 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
• Uncontrollable or symptomatic hypercalcemia
• Clinically uncontrolled active infection, including but not limited to acute pneumonia;
• Uncontrollable major epileptic seizure or superior vena cava syndrome
• Previous or current combination with other malignancies ;
• History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening;
• Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease;
• Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle;
• Vaccination of live-virus vaccine within 30 days after the start of planned treatment