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OncoMatch/Clinical Trials/NCT06926790

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

Is NCT06926790 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nivolumab & Ipilimumab for lung cancer - non small cell.

Phase 2RecruitingThe First Affiliated Hospital of Guangzhou Medical UniversityNCT06926790Data as of May 2026

Treatment: Nivolumab & IpilimumabNeoadjuvant 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.

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Extracted eligibility criteria

Biomarker criteria

Required: EGFR wild-type

without EGFR, ALK mutation

Required: ALK wild-type

without EGFR, ALK mutation

Required: PD-L1 (CD274) no known expression or ≤ 1% (no known expression or ≤ 1%)

no known PD-L1 expression or PD-L1 ≤ 1%

Disease stage

Required: Stage II, IIIA

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Cannot have received: radiotherapy

Lab requirements

Kidney function

No major organ dysfunction, including liver, kidney, and cardiac function

Liver function

No major organ dysfunction, including liver, kidney, and cardiac function

Cardiac function

No major organ dysfunction, including liver, kidney, and cardiac function

No major organ dysfunction, including liver, kidney, and cardiac function

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