non-small cell lung cancer
Conditions
Interventions
Control group:DP or AP chemotherapy+Tislelizumab
Experimental group:DP or AP chemotherapy+Tislelizumab+Atorvastatin
Sponsors
Army Specialty Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histological and pathological diagnosis of non-small cell lung cancer, and clinical stage IIIB or IV (AJCC, 8th edition, 2017) 3. EGFR wild-type, and ALK and ROS1 fusion gene negative 4. Have not received tumor-related treatment, and cannot receive radical surgery or radiation therapy; 5. Have measurable disease (RECIST, version 1.1) 6. Evaluate according to the activity status scale developed by the Eastern Cooperative Oncology Group (ECOG), and include patients with an ECOG score of 0-1; 7. Adequate organ function: (1) Blood routine (no blood transfusion within 14 days before treatment, no use of granulocyte colony stimulating factor (G-CSF), no correction with other drugs) 1) Neutrophil count (NE)>1500/µL; 2) Hemoglobin count (HGB) > 8.0 g/dL; 3) Platelet count (PLT) > 100 000/µL; (2) Blood biochemistry (liver and kidney function) 1) Serum creatinine (Cr) <= 1.5 x upper limit of normal (ULN); 2) Total bilirubin (TBIL) <= 1.5 x ULN; 3) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <= 2 x ULN. 8. Sign the informed consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients who have received the following medical interventions within four weeks before treatment: (1) Participate in drug treatment in other clinical studies; (2) History of vaccination with live attenuated vaccines; 2. Previously received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibody, cytotoxic lymphocyte-associated antigen 4 (cytotoxic lymphocyte-associated antigen 4) T lymphocyte-associated antigen-4, CTLA-4) antibody or other immune or molecular targeted therapy; 3. Known EGFR sensitive mutation or ALK fusion; 4. Complicated history of interstitial lung disease or non-infectious pneumonia; 5. Previous use of immunosuppressive drugs glucocorticoids within 7 days before starting treatment; 6. There is any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Active infection before treatment (such as need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5 degree C during screening/before the first dose; 8. Any other malignant tumor was diagnosed before treatment; 9. Known to be allergic to the study drug or any of its excipients, or to have severe allergic reactions to other monoclonal antibodies; 10. Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures; 11. The investigator evaluates patients with a follow-up time of less than 3 months (excluding progression or death within 3 months); 12. Patients with active liver disease, including unexplained hepatic aspartate aminotransferase and/or alanine aminotransferase levels persistently elevated; 13. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects, may confuse the research results, or affect the subjects to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Duration of Response;Adverse Effects Rate; | — |
Countries
China
Contacts
Public ContactZhong Zhaoyang
Army Specialty Medical Center
Outcome results
None listed