Neoadjuvant Therapy of SBRT Sequencial with Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)
Trial Parameters
Brief Summary
This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 -75 years, regardless of gender； 2. ECOG score 0-1; 3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC ; 4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1; 5. Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization ; 6. According to the doctor's judgment, lung function can meet the requirements of pneumonectomy; 7. Confirming the absence of EGFR/ALK sensitive gene mutations through molecular pathological diagnosis of the organization; 8. Good organ function: Bone marrow function: absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥9 g/dL; Liver function: total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance rate ≥ 60 mL/min; blood urea nitrogen ≤ 200mg/L; 9. Having suff