Surgically resectable or potentially resectable stage II–III NSCLC
Conditions
Interventions
Experimental group:Spatial Fractionated SBRT combined with Toripalimab plus hemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged = 18 years; 2. Eastern Cooperative Oncology Group performance status of 0 or 1; 3. Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the 8th edition of the American Joint Committee on Cancer staging system; 4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; 5. Adequate pulmonary function, as assessed by the surgeon, to tolerate the planned lung resection; 6. Absence of sensitizing EGFR mutations or ALK rearrangements confirmed by tissue-based molecular pathological testing; 7. Adequate organ function, defined as follows: Bone marrow function: absolute neutrophil count >= 1.5 × 10^9/L, platelet count >= 80 × 10^9/L, and hemoglobin >= 9 g/dL,Liver function: total serum bilirubin = 60 mL/min; blood urea nitrogen (BUN) <= 200 mg/L. 8. Fully informed of the study and voluntarily provided written informed consent. 9. Male patients of reproductive potential and female patients of childbearing potential must use effective contraception (e.g., oral contraceptives, intrauterine devices, or barrier methods combined with spermicide) throughout the study period and continue contraception for 6 months after completion of study treatment.
Exclusion criteria
Exclusion criteria: 1. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined per the Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-Small Cell Lung Cancer (2019 Edition), including partial stage IIIA, all stage IIIB and all stage IIIC diseases. This typically encompasses N2 disease with a single mediastinal lymph node short-axis diameter >= 3 cm or multi-station fused lymphadenopathy (lymph node short-axis diameter >= 2 cm on CT); T4 tumors invading the esophagus, heart, aorta or pulmonary veins; and all N3 disease; 2. NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid neoplasms; 3. Participants with known EGFR sensitizing mutations or ALK translocations. For non-squamous subjects, EGFR and ALK mutation status must be confirmed; 4. Prior treatment with PD-1/PD-L1 agents or other therapeutics targeting T cell receptors (e.g., CTLA-4, OX-40 agonists/antagonists, etc.); 5. Confirmed or suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Exceptions: type 1 diabetes mellitus and hypothyroidism controlled with stable-dose replacement therapy, cutaneous disorders not requiring systemic therapy (e.g., psoriasis, vitiligo); 6. Prior history of grade >= 2 interstitial lung disease; 7. Systemic corticosteroids (prednisone >10 mg daily or equivalent) or other immunosuppressive agents administered within 14 days prior to the first study treatment; 8. History of immunodeficiency, including other acquired or congenital immunodeficiency disorders, prior organ transplantation, allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 9. Vaccination with live vaccines within 4 weeks prior to the first study treatment; 10. Severe cardiovascular and cerebrovascular disease, defined as any of the following: (1) Uncontrolled hypertension or pulmonary arterial hypertension; (2) Unstable angina pectoris, or myocardial infarction, coronary artery bypass grafting or stent implantation within 6 months before study treatment initiation; (3) Chronic heart failure with New York Heart Association (NYHA) functional class >= II; (4) Left ventricular ejection fraction (LVEF) 450 msec in males or >470 msec in females, complete left bundle branch block, third-degree atrioventricular block; (6) Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurring within 6 months prior to study treatment initiation; 11. Uncontrolled or severe underlying comorbidities, including but not limited to active infection requiring systemic antibiotic therapy; 12. Positive human immunodeficiency virus (HIV) antibody test, or active hepatitis B or hepatitis C. The following populations are eligible for trial enrollment: (1) Subjects positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), with HBV DNA below the lower limit of quantification (negative) or <500 IU/mL, and deemed free of active hepatitis B infection by the investigator based on clinical treatment and manifestations; (2) Subjects positive for hepatitis C antibody with HCV RNA below the lower limit of quantification (negative); 13. Confirmed active tuberculosis (TB). Patients with suspected active TB mus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival rate (2-year EFS rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival;Major pathological response rate;Safety;Overall Survival;Objective Response Rate;R0 resection rate;Pathological Complete Response Rate; | — |
Countries
China
Contacts
Public ContactChang Chen
Shanghai Pulmonary Hospital
Outcome results
None listed