js001 combination therapy in nsclc negative driving gene after first-line chemotherapy.

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase ii, open, single-center clinical study to evaluate the efficacy and safety of js001 combined with axitinib in the treatment of advanced non-small cell lung cancer without activated egfr mutation, alk fusion and ros fusion after or during first-line chemotherapy. about 50 subjects will be included in this study and will be treated with js001 combined with acitinib. each cycle is 21 days.


Eligibility criteria:
inclusion criteria: 1. signed the informed consent form (icf); 2. recurrent or advanced stage ⅲ b or iv non-small cell lung cancer tested for egfr mutation and alk, ros1 fusion gene, and all the driving gene was negative. 3. at least one measurable lesion (according to recist 1.1); 4. failure of previous first-line standard chemotherapy: 5. patients who agreed to provide previously stored tumor tissue specimens or fresh biopsies of tumor lesions 6. age 18-75 years old, regardless of gender; 7. ecog score 0-1; 8. expected survival time ≥ 3 months; 9. laboratory test value must show enough organ function exclusion criteria: 1. tumor histology or cytological pathology confirmed the presence of small cell lung cancer components, or sarcomatoid lesions; 2. those who did not have a driving gene test; 3. investigator believed that there was a clear bleeding tendency 4. subjects who are currently participating in and receiving treatment in other studies, less than 4 weeks 5. patients who had previously received second-line or more systemic chemotherapy for advanced nsclc; 6. patients who had received hematopoietic stimulating factors, within one week before the start of the study. 7. uncontrollable or symptomatic hypercalcemia 8. within 6 months before receiving the study treatment, they received chest (lung) radiotherapy \> 30gy, or received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases. 9. the adverse reactions of previous antineoplastic therapy have not yet recovered to ctcae 5.0 grade ≤ 1 (except alopecia); 10. major surgery or radiotherapy has been performed within 4 weeks before joining the group or has not yet fully recovered from the previous operation 11. known active central nervous system (cns) metastasis and / or cancerous meningitis; 12. spinal cord compression without radical treatment of surgery and / or radiotherapy; 13. uncontrolled tumor-related pain; 14. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ; 15. evidence of active pneumonia was found; 16. clinically uncontrolled active infections; 17. uncontrollable major seizures or superior vena cava syndrome; 18. past or present co-existence of other malignant tumors; 19. liver diseases known to be of clinical significance; 20. those who have previously used any anti-pd-1 antibody, anti-pd-l1 antibody, anti-pd-l2 antibody or anti-ctla-4 antibody and axitinib; 21. patients with active tuberculosis (tb); 22. patients with any active autoimmune disease or history of autoimmune disease; 23. any anti-infective vaccine; 24. known (hiv) infection of human immunodeficiency virus; 25. the researchers believe that it can affect study compliance; 26. patients who received systemic immunosuppressive drugs within the first 4 weeks of the first day of the first cycle; 27. history of severe allergy, anaphylaxis or other hypersensitivity to chimeric or humanized antibodies or fusion proteins; 28. those who are known to be allergic to biological drugs; 29. those who are known to be allergic to acitinib; 30. patients with a history of arterial or venous thromboembolism; 31. known hereditary or acquired bleeding and thrombotic tendencies; 32. patients who have previously received allogeneic stem cell or parenchyma organ transplantation; 33. pregnant or lactating women or women of childbearing age who were positive for serum pregnancy test before taking the drug for the first time