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This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy | Experimental | neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy |
|
| toripalimab and platinum-based chemotherapy | Active Comparator | toripalimab and platinum-based chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Radiation | spatially fractionated stereotactic body radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year event-free survival rate | 2-year event-free survival rate | 2-year event-free survival rate |
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Inclusion Criteria:
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 ≤1.5 × upper limit of normal; alanine aminotransferase and aspartate aminotransferase ≤1.5 × upper limit of normal; Renal function: serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥60 mL/min, and blood urea nitrogen ≤200 mg/L;
Exclusion Criteria:
Poorly controlled hypertension or pulmonary hypertension;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Di Liu | Contact | +8617621320272 | liudi_2012@hotmail.com |
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| neoadjuvant immunotherapy | Drug | Toripalimab IV (dose 240mg) Q3W |
|
| Neoadjuvant Chemotherapy | Drug | Squamous cell carcinoma: Paclitaxel (175mg/m²) or Docetaxel (60-75 mg/m²) or Nab-paclitaxel (260mg/m²) plus Carboplatin (AUC=5)/Cisplatin (75 mg/m²) (to be determined by researchers); Non-squamous cell carcinoma: Pemetrexed (500mg/m²) plus Carboplatin/Cisplatin (to be determined by researchers) |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
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