non-small cell lung cancer (NSCLC)
Conditions
Interventions
Control Group:Platinum-based doublet chemotherapy and PD-1/PD-L1 monoclonal antibody treatment. At the same time, it is also possible to provide preventive or symptomatic treatments such as hormones,
Test Group:Coriolus Versicolor Intracellular Glycopeptide oral solution treatment, platinum-containing doublet chemotherapy, PD-1/PD-L1 monoclonal antibody treatment. At the same time, it is possible
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The trial participant must be able to understand the procedures and methods of this study, communicate well with the investigator, be willing to strictly comply with the clinical trial protocol to complete the trial, and voluntarily sign a written informed consent form. 2. Age = 18 years, with no gender restriction. 3. Histologically and/or cytologically confirmed driver gene-negative Stage III or Stage IV non-small cell lung cancer (NSCLC). 4. No prior systemic anti-tumor therapy; or the interval between the last systemic anti-tumor drug treatment and enrollment is = 6 months. 5. Expected survival = 12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1. 7. At least one measurable target lesion per RECIST 1.1 criteria, and the lesion has not received prior radiotherapy. 8. Adequate organ function, cardiac function and pulmonary function. 9. Eligible participants of reproductive potential (male and female) must agree to use a reliable contraceptive method (barrier method or abstinence) with their partner during the trial and for at least 3 months after the last study drug administration. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Participants with symptomatic brain metastases requiring steroid therapy. Participants with a prior diagnosis of brain metastases will be eligible for this study if they have completed treatment prior to screening, have recovered from acute adverse reactions caused by radiotherapy or surgical treatment, have discontinued corticosteroid therapy for brain metastases for at least 4 weeks, and are currently neurologically stable. 2. Received any anti-tumor therapy within 6 months prior to the first dose of study drug, including chemotherapy, growth factors, small-molecule targeted therapy, immunotherapy, or monoclonal antibody therapy. 3. Underwent major surgery on vital organs (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose, or requires elective surgery during the trial period. 4. Current or previous history of other malignancies (except adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless treated with radical therapy with no evidence of recurrence or metastasis for the past 5 years. 5. Confirmed or suspected history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonia, idiopathic pneumonia, or other moderate to severe pulmonary diseases that severely impair lung function. 6. Patients with severe hepatic or renal disease, including diagnosed severe active liver disease such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST > 2.0 × ULN; diagnosed severe active renal disease, severe renal insufficiency, or serum creatinine > 1.5 × ULN. 7. Presence of clinically significant active infection: bacterial, fungal, or viral infection, including tuberculosis, hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, human immunodeficiency virus (HIV) infection, or known acquired immunodeficiency syndrome (AIDS)-related diseases; 8. Unstable or severe comorbidities within 6 months prior to enrollment; 9. Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion, judged by the investigator as unsuitable for enrollment; 10.) Current or recent (within 3 months) any gastrointestinal disease that may affect the ability to swallow and/or absorb the study drug (e.g., gastrointestinal surgery, malabsorption syndrome, etc.). 11. Patients with diabetes mellitus; 12.Persons with known hypersensitivity to any active ingredient or excipient of the study drug; 13. Pregnant or lactating women; 14. Trial participants with drug abuse or chronic heavy alcohol consumption that may interfere with the evaluation of trial results; 15. Any psychiatric or cognitive impairment that may limit the participant’s understanding of the Informed Consent Form (ICF), implementation of study procedures, and compliance with the study; 16. Other conditions deemed by the investigator to render the participant unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in immune function compared to baseline after the last treatment (CD4/CD8 ratio, CD3, CD4, CD8) ;Changes in cancer patients' quality of life scale (EORTC QLQ?C30) scores compared to baseline after the last treatment ;Changes in cancer fatigue scale (CFS) scores compared to baseline after the last treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD56+/CD16+ ratio;Tumor markers (CEA, CA125, CYFRA21-1, SCC, NSE);Biomarkers: IL-6, IL-2, IL-4, IL-10, IgG, IgA, IgM, IgE;Objective Response Rate (ORR);Disease Control Rate (DCR) ;Duration of Response (DoR); | — |
Countries
China
Contacts
Public ContactYing Zhang
West China Hospital of Sichuan University
Outcome results
None listed