Lung Cancer
Conditions
Interventions
experimental group (single arm study):tislelizumab combined with cisplatin or carboplatin + pemetrexed
Sponsors
The First Affiliated hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old. 2. ECOG performance status = 1. 3. Histologically confirmed, locally advanced (Stage IIIB,IIIC) not amenable to curative surgery or radiotherapy, or metastatic (Stage IV) non-squamousNSCLC. 4. Patients must be able to provide documentation of muted KRAS reported by a tissue-based test or blood-based test. 5. Patients must have at least one measurable lesion as defined per RECIST v1.1. 6. Life expectancy = 12 weeks. 7. Patients with stable brain metastasis are allowed to be included and local treatment for brain metastasis is allowed. 8. Have had no prior systemic chemotherapy for advanced or metastatic NSCLC. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a disease-free interval of at least 6 months from the last dose of chemotherapy and/or radiotherapy prior to study treatment. 9. Patients must have adequate organ function as indicated by the following laboratory values (obtained within 14 days prior to study treatment): (1) Absolute neutrophil count (ANC) = 1.8 x 109/L, platelets = 100 x 109/L, hemoglobin = 80 g/L. Note: Patients must not have required a blood transfusion or growth factor support = 14 days before sample collection. 10. Aspartate and alanine aminotransferase (AST and ALT) < 2.5 x ULN or AST and ALT = 5 x ULN for patients with liver metastases ;Serum total bilirubin = 2.5 x ULN. 11. Alburmin(ALB)=30 g/L. 12. Creatinine(Cr)=1.5 ULN,International normalized ratio (INR) or activated partial prothrombin time (APTT) = 1.5 x ULN. 13. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and have a negative urine or serum pregnancy test = 3 days of study treatment. 14. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
Exclusion criteria
Exclusion criteria: 1.Active leptomeningeal disease or uncontrolled, untreated brain metastasis; ongoing requirement for corticosteroids (> 10 mg daily of prednisone or equivalent) as therapy for CNS disease;Stereotactic radiation within 7 days or whole-brain radiation within 14 days or surgery within 28 days for brain metastasis prior to the first administration of the study treatment. 2.Received > 30 Gy of radiation for non-lung lesions within 28 days or for lung lesions within 6 months prior to the first administration of the study treatment. 3.Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation orALK gene translocation. 4.Received prior treatment with EGFR inhibitors or ALK inhibitors. 5.Any active malignancy =5 years before study treatment, except for the specific cancer hat has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). 6.Active autoimmune diseases or history of autoimmune diseases that may relapse. Patients with the following diseases are not excluded and may proceed to further screening: Controlled Type I diabetes, Hypothyroidism (provided it is managed with hormone replacement therapy only). 7.With history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, etc. 8.Any of cardiovascular criteria meeting New York Heart Association Classification III or IV or any history of cerebrovascular accident 3months before the first administration of study treatment. 9.Any history of acute myocardial infarction = 3 months before the first administration of study treatment. 10.Any history of heart failure meeting New York Heart Association Classification III or IV (Appendix 5) = 3months before the first administration of study treatment. 11.Left ventricular ejection fraction(LVEF) 500 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled. 17.Severe chronic or active infections of tuberculosis = 12 months before study treatment. 18.Any major surgical procedure = 28 days before the first administration of study treatment. 19.Severe active infections requiring systemic antibacterial, antifungal or antiviral therapy within 4 weeks prior to the first administration of study treatment. 20. active infection (CTCAE=2) received therapeutic oral or IV antibiotics within 2 weeks prior to the first administration of study treatment. 21.Prior allogeneic stem cell transplantation or organ transplantation. 22.Received prior therapies targeting CTLA-4, PD- 1 or PD-L1. 23.Received prior therapies targeting VEGF or VEGFR. 24.Local treatment with any anti-cancer drugs approved or in clinical research stage. 25.Treatment with systemic immune-stimulatory agents (including but not limited to interferons, interleukin-2, and tumor necrosis factor) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to study treatment. 26.Any condition that required systemic tre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) ;Disease Control Rate (DCR); Duration of Response (DOR);Overall Survival (OS);Safety; | — |
Countries
CHINA
Contacts
Public ContactLing Wang
The First Affiliated Hospital of Dalian Medical Uniersity
Outcome results
None listed