Neoadjuvant immunotherapy followed by surgery has emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, conventional chemotherapy components may increase treatment-related toxicity, particularly in elderly populations. Additionally, the efficacy of preoperative immunochemotherapy for patients with PD-L1 expression \<1% remains to be improved. Emerging evidence has demonstrated that the combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) provides superior responses in the treatment of advanced NSCLC. However, the safety and efficacy of this strategy in the neoadjuvant setting remain controversial. Therefore, this single-arm clinical trial aims to evaluate the safety and feasibility of neoadjuvant nivolumab plus ipilimumab followed by surgery in treating locally advanced and resectable NSCLC.
Informed consent must be signed.
At least 18 years of age.
Histologically or cytologically confirmed non-small cell lung cancer (without EGFR, ALK mutation).
Have measurable and clinical stage II-IIIA with no known PD-L1 expression or PD-L1 ≤ 1%.
Patients with active autoimmune disease or history of autoimmune disease.
Patients have received other treatment for non-small cell lung cancer or for any other malignancy.
History of allergy to study drug components.
Pregnant or breast-feeding.
Single group
Nivolumab & Ipilimumab
DrugThis study evaluates the safety and efficacy of neoadjuvant nivolumab plus ipilimumab for IIA-IIIB NSCLC. Based on preliminary trial results, this study proposes a new treatment regimen.
Pathological Complete Response (PCR)
Pathological complete response is predefined as no residual viable tumor cells in primary tumor and lymph nodes.
3-year Event-Free Survival (3-year EFS）
The starting point for EFS was the initiation of neoadjuvant treatment. The endpoint for EFS was defined as the date of death, recurrence, progression, or the last follow-up.
Major Pathological Response (MPR)
Major pathological response defined as less than 10% of viable tumor cells in primary tumor.
Safety (Rate of grade 3 and higher grade treatment-related adverse events (TRAEs))
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Radiological Response
Radiographic response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
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