Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer
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%.
• disease eligible for surgery.
• No previous systematic therapy or radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least one measurable lesion.
• No major organ dysfunction, including liver, kidney, and cardiac function.