Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. Informed consent must be signed. 2. At least 18 years of age. 3. Histologically or cytologically confirmed non-small cell lung cancer (without EGFR, ALK mutation). 4. Have measurable and clinical stage II-IIIA with no known PD-L1 expression or PD-L1 ≤ 1%. 5. disease eligible for surgery. 6. No previous systematic therapy or radiotherapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. At least one measurable lesion. 9. No major organ dysfunction, including liver, kidney, and cardiac function. Exclusion Criteria: 1. Patients with active autoimmune disease or history of autoimmune disease. 2. Patients have received other treatment for non-small cell lung cancer or for any other malignancy. 3. History of allergy to study drug components. 4. Pregnant or breast-feeding. 5. Any mental or psychological condition that would prevent the patient from completing the study or understanding the patient information. 6. Patients who have other mali