Lung Cancer
Conditions
Interventions
Experimental group:SBRT radiotherapy + LDI radiotherapy + Adebelizumab
Sponsors
The 901st Hospital of the PLA Joint Logistic Support Force
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: A) the patient must sign a written informed consent prior to any study of specific procedures. B) histologically confirmed as squamous or non-squamous NSCLC without EGFR or ALK positive mutation, clinical stage = IIIB (lung cancer 8th edition AJCC staging system). C) the expression of PD-L1 is not limited, but it is recommended that all patients should be examined thoroughly to facilitate later data stratification analysis. D) patient age = 18 years old. E) expression status of Eastern Cancer Cooperation Group (ECOG) 0-1. F) Life expectancy > 3 months. G) measurable target lesions assessed with RECIST version 1.1. H) Metastasis and / or primary tumors comply with the dose limit of SBRT radiotherapy (according to QUANTEC review). I) patients must meet the defined thresholds of the following laboratories within 14 days prior to the first study treatment to ensure adequate organ function: 1) absolute neutrophil count = 1.5 × 109 / L. 2) Platelet = 80 × 109 shock L. 3) hemoglobin = 90g/L. 4) Serum Cr = 1.5 × normal upper limit (upper limit of normal,ULN) or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula). 5) bilirubin = 1.5 × ULN, Gilbert syndrome allows 3 × ULN. 6) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN (liver metastasis permission = 5 × ULN). 7) Alkaline phosphatase (ALP) = 2.5 × ULN (bone or liver metastasis allowed = 5 × ULN). 8) International standardized ratio of coagulation function (international normalized ratio, INR) = 1.5 × ULN, activated partial thromboplastin time (activated partial thromboplastin time, APTT) = 1.5 × ULN (unless receiving anticoagulant therapy). j) Women and men with reproductive potential must agree to adequate contraception during their participation in the study and within 6 months after the completion of treatment / treatment. k) patients are willing and able to follow the treatment plan during the study, including treatment and regular visits, as well as examinations including follow-up
Exclusion criteria
Exclusion criteria: A) non-squamous non-small cell lung cancer with targeted EGFR mutations or ALK fusion. B) patients who had previously received various immunotherapies and eventually developed into advanced NSCLC patients were still eligible, but the minimum immune elution period was = 3 months. C) patients who are unable to meet the basic clinical needs of radiotherapy (such as inability to lie down, epilepsy or restless leg syndrome). D) patients who received radiotherapy within 3 months prior to enrollment. E) leptomeningeal metastasis so that the target area is undefinable. F) patients with active (symptoms or requiring steroid treatment) central nervous system (CNS) metastasis and / or evidence of cancerous meningitis. Patients with asymptomatic brain metastasis who do not need steroids can be included. G) patients with active autoimmune diseases (except patients with hypothyroidism who are treated with hormone replacement therapy and keep their condition stable). H) symptomatic interstitial lung disease. I) need to use glucocorticoid drugs before treatment, and daily > 10mg dexamethasone or equivalent dose of other drugs. J) other invasive malignant tumors occurred in the past 2 years. K) known AIDS (AIDS) or serious uncontrolled complications. L) currently known active infections include hepatitis B and hepatitis C. M) patients who received novel coronavirus vaccination within 28 days prior to registration. N) patients with any other disease or disease that requires hospitalization or is incompatible with research treatment are not eligible. Patients are unable to comply with their research obligations due to geographical, social or physical reasons, or cannot understand the purpose and procedures of the study. O) pregnant or lactating women. P) Persons deprived of their liberty or in protective detention or guardianship. Q) for patients with a history of allergy to possible drug use. R) patients who underwent major surgery within one month before the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactLV Donglai
The 901st Hospital of the PLA Joint Logistic Support Force
Outcome results
None listed