Resectable stage II-IIIA non-small cell lung cancer
Conditions
Interventions
treatment group:stereotactic body radiation therapy (SBRT) combined with perioperative immunoneoadjuvant therapy following chemo-immunotherapy induction
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign a written informed consent form and be able to comply with the visits and related procedures stipulated in the protocol. 2.Age >= 18 years old. 3.Patients with untreated non-small cell lung cancer (NSCLC) at stage II-IIIA (according to the 8th edition of the Thoracic Tumor Staging system by the IASLC), confirmed by cytology/histology (via percutaneous lung biopsy, electronic bronchoscopy, mediastinoscopy, etc.). 4.For non-squamous NSCLC subjects, genetic testing is necessary to confirm the absence of EGFR sensitizing mutations and ALK rearrangements. For squamous NSCLC subjects, genetic testing is not mandatory, but those with known EGFR sensitizing mutations or ALK rearrangements should not be enrolled in the study. 5.Considered suitable for radical resection. 6.Have at least one measurable lesion according to RECIST V1.1. 7.ECOG score of 0-1. 8.Have adequate organ and marrow function, Laboratory test values within 7 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous drugs to correct hematological or hepatorenal dysfunction are allowed within 14 days prior to obtaining laboratory tests), as follows: (1) Adequate hematological function, defined as neutrophil absolute count >=1.5×10^9 /L, platelet count >=100×10^9 /L, hemoglobin >=100g/L; (2) Adequate liver function, Defined as total bilirubin level =35g/L; (3) Full renal function, Serum creatinine (Scr) =60 mL/min (calculated using Cockcroft/Gault formula) and urine protein (UPRO) < 2+ or 24-hour urine protein quantitation < 1g. Cockcroft/Gault formula: For women: CrCl= (140-age) × Body weight (kg) × 0.85/(72 × serum creatinine (mg/dL)) Male: CrCl= (140-age) × Body weight (kg) × 1.00/(72 × serum creatinine (mg/dL)) (4) The International standardized ratio (INR) <=1.5×ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) <=1.5×ULN during the 7 days prior to study treatment. 9.For female subjects of childbearing potential, a negative urine or serum pregnancy test within 7 days prior to the first administration of the study drug is required. If the result of the urine pregnancy test is positive, a blood pregnancy test is required.
Exclusion criteria
Exclusion criteria: 1.Currently participating in another interventional clinical study and have received treatment with other study drugs or devices within the 4 weeks prior to the start of the current study treatment. 2.Previous use of anti-PD-1, anti-PD-L1, anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs targeting T-cell costimulatory or immune checkpoint pathways (such as OX40, CD137, etc.), as well as adoptive cellular immunotherapy. 3.Within 2 weeks prior to enrollment, the subject has received Chinese herbal medicines, proprietary Chinese medicines with antitumor indications, or drugs with immunoregulatory effects (including thymosin, interferon, and interleukin). 4.There are unhealed surgical wounds, ulcers, or fractures. 5.Patients requiring long-term systemic use of corticosteroids; those who are receiving any other form of immunosuppressive therapy within 7 days prior to enrollment. Note: Intranasal, inhaled, or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (<=10 mg/ day of prednisone or equivalent doses of drugs) or for preconditioning (e.g., to prevent hypersensitivity to contrast media) are permitted. 6.Within 1 year prior to enrollment, there was a history of non-infectious pneumonitis requiring glucocorticoid therapy or the presence of current interstitial lung disease. 7.Within 2 years prior to enrollment, there was a history of active autoimmune diseases requiring systemic therapy (such as disease-modifying drugs, corticosteroids, or immunosuppressants), including but not limited to inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), diverticulitis, celiac disease, systemic lupus erythematosus, sarcoidosis or Wegener's granulomatosis (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, multiple sclerosis, vasculitis, glomerulonephritis, antiphospholipid syndrome, hypophysitis, uveitis, etc. Replacement therapy (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy. Patients with positive autoimmune antibodies may be enrolled only after the investigator assesses and confirms the absence of autoimmune diseases requiring systemic therapy. 8.A history or current presence of myocarditis. 9.A genetic bleeding tendency or coagulation disorder, or a history of thrombosis: any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, or pulmonary embolism, within 6 months prior to enrollment. A history of deep venous thrombosis or any other severe thrombotic embolism within 3 months prior to enrollment (implantation-related venous port or catheter-related thrombosis, or superficial venous thrombosis are not considered as "severe" thrombotic embolism). 10.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive) and known active syphilis. 11.Active tuberculosis or tuberculosis requiring medical intervention at this stage, including but not limited to pulmonary tuberculosis. 12.Active hepatitis B. (1) Hepatitis B subjects who met the following criteria were eligible for inclusion: HBsAg (+) or HBcAb (+), with a pre-enrollment HBV viral load <1000 copies /ml or <200 IU/ml or lower than detected Lower limit. (2)HBsAg (+) subjects should receive anti-HBV therapy thr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR, Major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR, Pathological complete response;safety; | — |
Countries
China
Contacts
Public ContactXu Shuangbing
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed