Non-small cell lung cancer
Conditions
Interventions
Control:PD-1 plus chemotherapy
Intervention group:PD-1 plus chemotherapy plus microecological preparation JK-5G
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-small cell lung cancer confirmed by histopathology or cytology,confirmed stage IIIB–IV NSCLC (according to WHO 2015 classification); (IASLC) Thoracic Tumor Staging Manual, 8th Edition); and the primary tumor or lymph node metastases are clearly negative for EGFR/ALK/ROS1; 2. At the time of signing the informed consent, the age is >=18 years old and <=75 years old, male or female; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. The expected survival period is not less than 12 weeks; had no previous systemic chemotherapy, had at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1), had Eastern Cooperative Oncology Group performance status of 0 or 1, and had a life expectancy of at least 3 months; 5. Evaluable disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 6. Subjects who have not received surgery, chemotherapy, radiation therapy and biological therapy for newly diagnosed non-small cell lung cancer; 7. Male and female patients of childbearing age agree to use reliable methods of contraception before entering the trial, during the study, and within 8 weeks after stopping the drug; 8. Subjects can be normal to eat through the mouth; 9. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any T cell costimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor, PD-1 inhibitor, PD-L1/2 inhibitor, or other T cell-targeting agent; 2. Known uncontrolled or symptomatic active central nervous system (CNS) metastases, manifested by the onset of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. Patients with a history of central nervous system metastases or spinal cord compression were eligible if they were clearly treated and clinically stable after 4 weeks of discontinuation of anticonvulsants and steroids before the first study dose. 3. Advanced patients with symptoms, who have disseminated to the viscera, and who are at risk for life-threatening complications in the short term (including patients with uncontrolled amounts of exudate [chest, pericardium, abdominal cavity]); 4. A history of idiopathic pulmonary fibrosis, organized pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically active pneumonia; Or other moderate-to-severe lung disease that seriously affects lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); 5. There is no active autoimmune disease or a history of autoimmune disease recurrence and expectations (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function decrease [just by hormone replacement therapy can control subjects can be incorporated into]; Subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes, or asthma that had completely resolved in childhood and did not require any intervention as adults were included; Patients with asthma requiring medical intervention with bronchodilators were excluded). 6. Subjects with active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within 48 weeks before screening, whether treated or not; 7. Severe infection at the time of randomization, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 8. Patients with myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention in the 6 months prior to study entry; 9. HBsAg positive and HBV DNA copy number greater than the upper limit of normal value (1000 copies /ml or 500IU/ml), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection); A known history of HIV positivity or known acquired immunodeficiency syndrome (AIDS); 10. Had other active malignant tumors within 2 years prior to study entry. Exceptions are basal or squamous cell carcinoma of the skin that can be treated locally and has been cured, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid. 11. Had undergone major surgery within 28 days before randomization or was scheduled to undergo major surgery during the study period; 12. Received antitumor therapy (including chemotherap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality Of Life;Objective Response Rate;Disease Control Rate;Adverse Effects Rate;CD4 + / CD8 + T lymphocytes count;16S DNA sequencing of gut microbiota;Blood inflammatory cytokines; | — |
Countries
China
Contacts
Public ContactYu Huiqing
Chongqing University Cancer Hospital
Outcome results
None listed