non-small cell lung cancer
Conditions
Interventions
single arm:SBRT
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 on the date of signing the informed consent; 2. Patients with early NSCLC who are not suitable for or unwilling to undergo surgery for various reasons: advanced age, serious medical disease, stage T1~3N0M0, confirmed by histology; 3. cannot or refuse to accept the pathological diagnosis should satisfy the following conditions may consider SBRT treatment to join in this study: (1) clear imaging in the diagnosis of lesions in long-term follow-up (> 2 years) in the process of progressive increase, or ground glass shadow density increased, the proportion increase or travel through blood vessels and edge burr samples change with malignant characteristics;At least two imaging studies (e.g., chest contrast CT and 1 to 3mm thin-slice CT, and whole body pet-ct) suggest malignancy;(2) Lung cancer was determined by MDT discussion;(3) Fully informed consent of patients and their families. 4. The newly treated patients did not receive any anti-tumor therapy; 5. ECOG-PS score 0~2; 6. Measurable lesions (according to RECIST V1.1); 7. Fertile men and women of reproductive age must agree to use effective contraceptive methods from the time of signing the informed consent form until 180 days after the last administration of the study drug.Women of childbearing age include pre-menopausal women and women within 2 years after menopause.Women of childbearing age must have a negative pregnancy test no later than 7 days before the first study drug was administered; 8. Adequate bone marrow, heart, lung, liver and kidney function: neutrophil count >=1.5 x 10^9/L, hemoglobin >=100g/L, platelet count >= 100 x 10^9/L, creatinine and total bilirubin values <= 1.5 times the upper limit of normal value, AST and ALT values <=2.5 times the upper limit of normal value;Prothrombin time (PT), international standardized ratio (INR) <=1.5 times the upper limit of normal value; 9. The patients voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. histology confirmed the composition of small cell lung cancer; 2. The presence of other primary malignancies within 5 years prior to the first administration of the study drug, excluding locally curable malignancies that have undergone radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate cancer, cervical or breast carcinoma in situ, etc.); 3. Any diseases or conditions contraindicated with SBRT and immune checkpoint inhibitors; 4. Female patients in pregnancy and lactation; 5. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and mechanized pneumonia; 6. Received live vaccine within 28 days prior to initial administration of the study drug; 7. Participants in or being treated in clinical trials of any other drug in the 28 days prior to the first administration of the study drug. 8. Have received any antibody/drug (including PD-1, PD-L1, CTLA4, TIM3, LAG3, etc.) targeting T cell co-regulatory proteins (immune checkpoints). 9. Have or have had an active or recurrent autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or are at risk of such disease (e.g., organ transplant requiring immunosuppressive therapy). Further screening is allowed for subjects with type 1 diabetes, hypothyroidism that requires only hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of an external trigger. 10. have been diagnosed with immunodeficiency disease or received systemic glucocorticoid therapy (e.g., hormone therapy equivalent to >10 mg prednisone per day) or have used any other form of immunosuppressive therapy within 14 days prior to first dosing. Note: Hormone equivalent to <= 10 mg of prednisone per day is permitted as adrenal replacement therapy if subjects do not have active autoimmune disease. Subjects were allowed to use topical, ocular, intraarticular, intranasal, and inhaled glucocorticoids (very low systemic uptake). Short-duration glucocorticoids are permitted for prophylaxis (e.g., for contrast hypersensitivity) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity due to contrast hypersensitivity). 11. Have interstitial lung disease and the disease is symptomatic; Subjects who are considered by the investigator to have a prior pulmonary history that might interfere with the determination or treatment of drug-related pulmonary toxicity should also be excluded. 12. Subjects who had a history of active tuberculosis infection within 1 year before the first drug administration and who had a history of active tuberculosis infection more than 1 year ago were considered suitable for inclusion if the investigator determined that there was no evidence of active tuberculosis at present. 13. Have a history of inflammatory enteritis or an existing inflammatory bowel disease (such as Crohn's disease and ulcerative colitis). 14. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 15. Subjects with chronic active hepatitis B or active hepatitis C. Screening period hepatitis B virus surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody positive subjects, Hepatitis B virus (HBV) DNA titer testing (excluding more than 25
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median progression-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| median Over Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactYongcun Wang
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed