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Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 9, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06926790). This is a study registration, not published results. Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 69 participants (ESTIMATED). Conditions: Lung Cancer - Non Small Cell. Interventions: DRUG: Nivolumab & Ipilimumab. Primary outcome measures: Pathological Complete Response (PCR) , Within 2 weeks after surgery. Brief summary: 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.