Non-Small Cell Lung Cancer
Conditions
Interventions
control group:Placebo combined with PD-1/PD-L1 inhibitors treatment
treatment group:Fuzheng Kang-Ai Formula combined with PD-1/PD-L1 inhibitors treatment
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage III or IV NSCLC confirmed by histology or cytology who are not amenable to surgery and have no driver gene mutations (or are resistant to targeted therapy) with any or unknown PD-L1 expression and who have received a PD-1/PD-L1 inhibitor-containing treatment regimen (including later lines of therapy); 2. Aged = 18 years and 3 months; 4. The investigator confirms according to the RECIST 1.1 criteria that the patient has at least one measurable lesion and that a lesion in the previously irradiated field or a lesion with prior local treatment that shows progression can be selected as a target lesion; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6. Adequate hematologic function defined as absolute neutrophil count = 1.5 × 10^9 /L platelet count = 100 × 10^9 /L hemoglobin = 90 g/L (no blood transfusion within 7 days); 7. Adequate liver function defined as total bilirubin = 1.5 times the upper limit of normal (ULN) and AST and ALT = 2.5 times ULN for all patients or for patients with liver metastasis AST and ALT = 5 times ULN; 8. Adequate renal function defined as creatinine clearance = 60 ml/min (Cockcroft-Gault formula); 9. Adequate coagulation function defined as International Normalized Ratio (INR) or prothrombin time (PT) = 1.5 times ULN; if the subject is receiving anticoagulant therapy PT should be within the range specified for the anticoagulant drug; 10. For women of childbearing potential a negative urine or serum pregnancy test within 3 days before the first administration of the study drug. If the urine pregnancy test cannot confirm a negative result a blood pregnancy test is required; 11. Voluntary participation in the study and signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Currently participating in an interventional clinical study treatment, or received other investigational drugs or medical devices within 4 weeks prior to the first dose. 2.Previously received drugs targeting another immune checkpoint or co-stimulatory T-cell receptor (such as CTLA-4, OX-40, CD137). 3.Underwent major surgery within 3 weeks prior to administration. 4.Has active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis that requires clinical intervention. 5.Has received solid organ or hematopoietic stem cell transplants. 6.Has clinically uncontrolled pleural effusion/ascites (patients without the need for drainage or with drainage stopped for 3 days with no significant increase in effusion can be included; if the effusion can be controlled with non-invasive methods, and no significant increase in effusion is observed after stopping drainage for 3 days, inclusion may be considered). 7.Tumor compressing surrounding vital organs (such as the esophagus) with related symptoms. 8.New York Heart Association (NYHA) Class III-IV congestive heart failure, poorly controlled with clinically significant arrhythmia. 9.Known allergy to the active ingredients or any excipients of PD-1/PD-L1 inhibitors. 10.Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. 11.Patients requiring long-term systemic corticosteroid use (patients who intermittently use bronchodilators, inhaled corticosteroids, or local corticosteroid injections for conditions like COPD or asthma can be included). 12.Symptomatic central nervous system metastases. 13.Lung cancer surgery patients who will not undergo immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;safety;overall survival OS;tolerability;1-year survival rate;objective response rate ORR;disease control rate DCR; | — |
Countries
China
Contacts
Public ContactSumei Wang
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed