JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer

Exclusion Criteria

• •Subjects who met any of the following criteria will be excluded from the study:
• •1. For the third line and second line populations with advanced lung squamous carcinoma (Cohorts 1 and 2), subjects who have received systemic anti-tumor therapy within 3 weeks before the first dose of study drug, including: chemotherapy, targeted therapy, anti-vascular drug therapy, biological therapy, immunotherapy, radiotherapy or other treatments with investigational products
• •2. Any adverse reactions caused by previous treatments have not recovered to CTCAE (Version 5.0) Grade 1 or below ;
• •3. Symptomatic metastases to central nervous system.;
• •4. Subjects with poorly controlled tumor-related pain who require analgesic treatment must receive the treatment at a stable dose before participating in the study;
• •5. Hydrothorax or ascites or pericardial effusion with clinical symptoms or unstable condition after symptomatic treatment;
• •6. Subjects previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
• •7. Known history of severe allergic reactions to JS004 or toripalimab and its components, scheduled chemotherapeutic drugs and their components;
• •8. Known active or suspected autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease;
• •9. History of interstitial lung disease or drug-induced interstitial lung disease or pulmonitis;
• •10. Received systemic corticosteroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive drugs within 14 days before the first study dose;
• •11. Subjects with a past history of immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation, or have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• •12. Had received live vaccines within 4 weeks before the first study dose;
• •13. Any major surgical procedure within 4 weeks before the first study dose. Planned major surgical procedure to be performed within 30 days after the first dose , or not fully recovered from the previous surgery;
• •14. Suffering from severe cardiovascular and cerebrovascular diseases;
• •15. Subjects with uncontrolled or serious underlying diseases, including but not limited to active infection requiring systemic antibiotic treatment;
• •16. Positive human immunodeficiency virus (HIV) antibody test, active hepatitis B or C;
• •17. Known active Pulmonary tuberculosis (TB)..
• •18. Any active malignancy other than the disease under study within the past 2 years, except for malignancies that can be expected to be cured after treatment;
• •19. Subjects who have a history of psychotropic drug abuse and are unable to withdraw or have mental disorder;
• •20. Pregnant or breastfeeding woman;
• •21. Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, at the discretion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.