non-small cell lung cancer (NSCLC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years at the time of signing the informed consent, no gender limit; 2. Locally advanced (stage IIIB/ stage IIIC) and stage IV non-small cell lung cancer with histopathological or cytological evidence that is inoperable and cannot be treated with radical chemoradiotherapy; 3. Negative gene mutation; 4. Previous first-line chemotherapy combined with immunization regimen; 5. ECOG score; 0 and 1; 6. According to RECIST v1.1, subjects must have measurable target lesions examined by CT or MRI; 7. Normal function of major organs; 8. Subjects of childbearing age must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment; 9. Signed the written informed consent, and expected to have good compliance with the research program.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed mixed NSCLC, including NSCLC subjects with small-cell lung cancer components; 2. Subjects with active BMS (subjects with stable symptoms after treatment with BMS can be included if the symptoms remain stable for at least 4 weeks); 3. Imaging evidence of tumor cavity, tumor surrounding or invasion of large vessels; 4. Use of immunosuppressive drugs within 28 days before first use of carrilizumab; 5. Received Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs within 28 weeks prior to initial administration; 6. Administer live attenuated vaccine within 30 days of the first administration or expected during the study period; 7. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites as determined by the investigator, or who had received serosal effusion drainage for therapeutic purposes within 4 weeks prior to treatment; 8. Subjects with severe infection within 1 month before enrollment; 9. Active autoimmune disease or immunodeficiency; 10. The subject received systemic treatment such as bronchodilator and was not satisfied with asthma control; 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 12. Receiving CYP3A4 inhibitors; 13. The subject has received or plans to receive a solid organ or blood system transplant (other than a corneal transplant) during the study period; 14. Subjects with a history of other malignant tumors within 5 years; 15. Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 16. Clinical symptoms or diseases of the heart that are not well controlled; 17. Abnormal coagulation function; 18. Clinically significant blood or daily hemoptysis of more than half a teaspoon (2.5ml) or more occurred within 2 months before enrollment; 19. Currently participating in interventional clinical research and treatment; 20. Have a clear history of allergy; 21. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 22. Increased risks associated with study or investigational drug participation and, in the investigator's judgment, other conditions in which the subject may not be eligible for study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of response; | — |
Countries
China
Contacts
301 Hospital, General Hospital of the People's Liberation Army