non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:PD-1 Inhibitor + Fuzheng Kang'ai Fang Granules
Control group:PD-1 Inhibitor + Fuzheng Kang'ai Fang Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the 8th edition of the TNM staging classification of lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Classification of Cancer, subjects with histologically or cytologically proven inoperable metastatic or recurrent (stage IV) NSCLC who have received first-line therapy, or first-line subjects who refuse chemotherapy; 2. PD-L1=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90g/L (no history of blood transfusion within 7 days); 9. Adequate liver function, defined as total bilirubin levels = 60 ml/min (Cockcroft-Gault formula); 11. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulant drugs; 12. For female subjects of childbearing age, a urine or serum pregnancy test should be negative within 3 days prior to receiving the first dose of study drug. A blood pregnancy test is required if a urine pregnancy test result cannot be confirmed negative; 13. Voluntarily join the study and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical research treatment, or receiving other investigational drug or investigational device treatment within 4 weeks before the first dose; 2. Previous therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 drug, or another drug that stimulates or synergistically inhibits T cell receptors (eg, CTLA-4, OX-40, CD137); 3. Received major surgical treatment within 3 weeks before administration; 4. Active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention; 5. Received solid organ or blood system transplantation; 6. There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need to drain the effusion or have no significant increase in the effusion after stopping the drainage for 3 days can be enrolled); 7. The tumor compresses surrounding important organs (such as esophagus) and is accompanied by related symptoms; 8. Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; 9. Complicated severe infection requires antibiotic treatment; 10. Known allergic reaction to PD-1 inhibitor active ingredients and or any excipients; 11. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years before the first dose; 12. Patients requiring long-term systemic corticosteroids. Patients who require intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids due to COPD or asthma may be enrolled; 13. Symptomatic central nervous system metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;disease control rate;1-year survival rate;quality of life;intestinal flora structure; | — |
Countries
China
Contacts
Public ContactWu Wanyin
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed