In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.
Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
Age ≥18 years;
(Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor > 7cm);
Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc;
Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
Single group
Chemotherapy
DrugPatients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.
Immunotherapy
DrugInvestigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.
Radical resection of lung cancer
Procedure/SurgeryRadical resection of lung cancer with lymph node dissection
SBRT
RadiationSBRT for primary lung lesion 8Gy\*3F after first cycle of chemoimmunotherapy
Pathological complete response (pCR)
Pathological complete response for surgical patients
Major pathologic response (MPR)
No more than 10% residual viable tumour in the resected tumour (up to 24 weeks)
1-year event-free survival (1 year EFS)
Interval between the start of neoadjuvant treatment and any progression of disease precluding surgical resection, progression of disease in the absence of surgery, progression or recurrence after surgery, or death from any cause, whichever occurred first
The R0 resection rate
The proportion of patients who had complete surgical resection \[R0\]
Incidence of treatment-related adverse events
The incidence of adverse events ≥ grade 3 during perioperative period
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