Lung Cancer
Conditions
Interventions
Treatmengt arm:Sintilimab Injection
Sponsors
Cancer Hospirtal Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to implementation of any trial-related procedures. 2. Aged 18 to 75 years. 3. Histologically- or cytologically-confirmed, Stage IIIB or IV Non-Small Cell Lung Cancer. 4. Patients with negative EGFR-sensitive mutation and ALK fusion gene test results by genetic testing; 5. Patients with high expression of PD-L1 (TPS>=50%) who were provided with detectable tissue samples before enrollment and confirmed by Dako 22C3; 6. Life expectancy of at least 3 months; 7. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 9. No prior systemic treatment for the treatment of the participant's advanced or metastatic Non-Small Cell Lung Cancer (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic Non-Small Cell Lung Cancer); 10. The main organs function normally: (1) Blood routine examination: (no blood transfusion, no use of G-CSF and no use of hematopoietic stimulating factors for correction within 14 days before screening) 1) Hemoglobin (HB)>=90 g/L; 2) Absolute neutrophil count (ANC) >=1.5*10^9/L; 3) platelet count (PLT) >= 100*10^9/L; (2) Biochemical examination: 1) TBIL = 60 ml/min(Cockcroft-Gault formula); (3) Good coagulation function, defined as INR<=1.5*ULN, or PT<=ULN+4sor APTT<=1.5*ULN; (4) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range; (5) Myocardial enzyme spectrum is within the normal range; 11. Female Subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods. non-fertile women are defined as at least 1 year postmenopausal or have undergone surgical sterilization or uterine sterilization cut. 12. Male Subjects with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception (a method with a failure rate of less than 1% per year) for the course of the study through 180 days after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed small cell lung cancer, including mixed non-small cell lung cancer and small cell lung cancer; 2. Known sensitizing mutation in the Epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene or (ROS proto-oncogene 1 , receptor tyrosine kinase) ROS1 fusion oncogene; 3. Known central nervous system metastases and/or carcinomatous meningitis; 4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); 5. Clinically uncontrollable pleural effusion/peritoneal effusion exists; 6. Subjects with previous malignancies within 5 years before the first administration; 7. Currently participating or has participated in a study of an investigational agent or receiving any other drug or using an investigational device; 8. Received systemic treatment of traditional chinease medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 9. Active autoimmune disease that has required systemic treatment in the past 2 years; 10. Immunosuppressive drugs were used within 7 days before the first administration, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids; 11. Subjects had or plan to have allogeneic bone marrow transplantation or solid organ transplant (except corneal transplantation); 12. History of severe hypersensitivity reactions to the active ingredients or excipients of the sintilimab; 13. Subjects had not recovered from the toxicity and/or complications of the most recent prior chemotherapy to Grade 1 or less (except alopecia or fatigue); 14. Known history of testing positive for human immunodeficiency virus (HIV); 15. Previously untreated active hepatitis B (defined as HBsAg-positive with detectable HBV-DNA copy number >500IU/ml); 16. Known history of active HCV (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection); 17. Subjects had administration of a live, vaccine within 30 days of the first dose of study treatment.Note: Received inactivated virus vaccine for seasonal influenza within 30 days before the first dose is allowed; however, intranasal live attenuated influenza vaccine is not allowed. 18. Female subjects who are pregnant, breast-feeding; 19. History of any serious or uncontrolled systemic disease 20. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator; 21. Subjects received radiation therapy of > 30 Gy to chest within 1 month of the first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Disease Control Rate;Overall Survival;Adverse events;Serious Adverse Reaction; | — |
Countries
China
Contacts
Public ContactWang Jie
Cancer Hospirtal Chinese Academy of Medical Sciences
Outcome results
None listed