Non-small cell lung cancer
Conditions
Interventions
control group:placebo
probiotics group:Bifidobacterium animalis subsp. lactis V9(Kex02)
Sponsors
Inner Mongolia People's hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be 18 years old >= the start of the study, with any gender restrictions; 2. NSCLC confirmed by histologic or cytological studies, and participants with stage III unresectable or stage IV tumors (as determined by the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumor Staging Manual, 8th edition); 3. Patients with genetic testing for EGFR(-) or ALK(-); 4. According to RECIST 1.1 criteria, subjects must have measurable lesions; 5. ECOG score of at least 0 or 1; 6. Subjects who have undergone any number of surgeries, interventional treatments, chemotherapy, radiotherapy, or other systemic treatments must meet all the following enrollment criteria to be eligible for this study: 7. Subjects who have never received systemic chemotherapy or immunotherapy for advanced/metastatic NSCLC; 8. Expected survival time greater than 6 months; 9. Vital organ function must meet the following requirements (no blood components, cell growth factors, white medicine, platelet-increasing drugs, or anemia correction drugs are allowed within 14 days before the first use of the investigational drug): (1) Absolute Neutrophil Count (ANC) > = 1.5×10^9/L; (2) Platelet > = 100×10^9/L; (3) hemoglobin > = 9 g/dL; (4) Serum albumin > = 2.8g/dL; (5) Total bilirubin < = 1.5× ULN, ALT, AST, and/or AKP < = 2.5× ULN; (6) Serum creatinine < = 1.5× ULN or creatinine clearance greater than 60 mL/min (Cockcroft-Gault, see Appendix 2); 10. Consent and ability to take a solid beverage containing the probiotic Bifidobacterium lactis V9 (Kex02); 11. Subjects must sign informed consent forms; 12. Subjects agreed to undergo follow-up medical imaging examinations to determine lesion progression and agreed to provide stool samples before and after taking the probiotic Bifidobacterium lactis V9 (Kex02) and at each follow-up; 13. Women of childbearing age must undergo a pregnancy test with a negative result within 7 days before starting treatment and be willing to use strict contraception until 120 days after the last immune checkpoint inhibitor.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, or not using effective contraception, and men who have active sexual activity with WOCBP and are not taking effective contraception; 2. Subjects with active central nervous system (CNS) metastases; 3. Subjects with a history of or concurrent other malignant tumors (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ); 4. Subjects previously treated with immune checkpoint inhibitors cannot be enrolled; subjects with known prior allergies to large protein drugs, any immune checkpoint inhibitors, or components of chemotherapy drugs used during treatment; 5. Subjects with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism—those who have had thyroid surgery cannot be included; subjects with vitiligo or childhood asthma fully resolved and requiring no intervention in adulthood can be included; subjects needing bronchodilator medical intervention for asthma cannot be included); 6. Subjects currently using immunosuppressants or systemic or absorbable local steroid treatments for immunosuppressive purposes (dose >10mg/day prednisone or equivalent steroid) and continuing use within 2 weeks before enrollment; 7. Patients with uncontrolled pleural or pericardial effusion, or ascites, requiring repeated drainage; 8. Subjects with poorly controlled cardiac symptoms or disease, such as: (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Coagulation abnormalities (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding tendencies, or receiving thrombolytic or anticoagulant therapy; 10. History or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (fresh blood >5 ml within 4 weeks), or thromboembolic events in the past 12 months (including stroke and/or transient ischemic attacks); 11. Subjects with active infections or unexplained fever >38.5°C during screening or before the first administration (fever caused by the tumor, as judged by the investigator, can be included); 12. Subjects with historical or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function; 13. Subjects with congenital or acquired immune deficiencies, such as those infected with HIV, or with active hepatitis (transaminases not meeting the inclusion criteria, for hepatitis B: HBV DNA >=10^3/ml; for hepatitis C: HCV RNA =10^3/ml); chronic hepatitis B virus carriers with HBV DNA <2000 IU/ml (<10^4 copies/ml) must be on antiviral treatment during the study to be eligible. 14. Subjects currently participating in other clinical studies or less than 1 month since the end of a previous clinical study; subjects may receive other systemic anti-tumor treatments during the study; 15. Subjects who have received live vaccines within 4 weeks before the study medication or might receive them during the study; 16. Subjects with a known history of substance abuse, alcoholism, or drug addiction; 17. Subjects who the investigator believes should be excluded from this study, for example, if the investigator judges that the su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokine;Intestinal mucosal barrier;Microbial metabolites;gut microbiota;Progression-free survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;objective response rate; | — |
Countries
China
Contacts
Public ContactDong Li
Inner Mongolia People's hospital
Outcome results
None listed