Non-small cell lung cancer
Conditions
Interventions
Control group:Placebo and PD-1/L1 inhibitors
Experimental group:Ginseng Polysaccharides and PD-1/L1 inhibitors
Sponsors
THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) stage IB–IIIB with measurable lesions; 3.Receiving PD-1/L1 inhibitor monotherapy or in combination with chemotherapy as neoadjuvant/induction therapy; 4.No prior chemotherapy or immunotherapy (e.g., PD-1/L1 inhibitors, CTLA-4 inhibitors); 5.ECOG performance status (PS) 0–1; 6.Adequate organ function meeting the following requirements (without any blood component or growth factor support during screening): (1) Hematology: Hemoglobin (HGB) >= 90 g/L; absolute neutrophil count (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 90×10^9/L; (2) Liver function: Total bilirubin (BIL) 60 mL/min; (4) Thyroid function: Thyroid-stimulating hormone (TSH) <= ULN (if abnormal, free T3/T4 levels should be assessed; patients with normal T3/T4 levels are eligible); 7.Women of childbearing potential must have practiced reliable contraception or have had a negative pregnancy test within 7 days prior to enrollment, and must be willing to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of study treatment; 8.The subject voluntarily participates in this study, signs the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically confirmed mixed non-small cell lung cancer, large cell carcinoma, or small cell lung cancer; 2.Pregnant or breastfeeding women; 3.Prior history of allogeneic bone marrow, stem cell, or solid organ transplantation; 4.Prior history of severe hypersensitivity to monoclonal antibodies or traditional Chinese medicine polysaccharides; 5.Presence of any active autoimmune disease or history of autoimmune disease; 6.Congenital or acquired immunodeficiency (e.g., HIV-infected individuals) or active hepatitis; 7.Poorly controlled cardiac clinical symptoms or diseases, including: (1) New York Heart Association (NYHA) class >= II heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 8.Poorly controlled severe pulmonary impairment or gastrointestinal disease; 9.History of systemic antibiotic therapy within 3 months prior to administration of the study drug; 10.Receipt of radiotherapy, grade 4 surgery, systemic anti-tumor therapy, or investigational drug therapy within 4 weeks prior to administration of the study drug; 11.Receipt of corticosteroids (>=10 mg/day prednisone or equivalent) or immunosuppressive agents within 14 days prior to administration of the study drug (topical, ophthalmic, inhaled, or intranasal corticosteroids are allowed); 12.According to the investigator’s judgment, any other factors that may compel premature termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors that could affect subject safety or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Event-Free Survival;Safety ;Overall Survival;Lymph node downgrading;Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactLiang Wenhua
THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY
Outcome results
None listed