RecruitingPhase 2NCT06926790

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

69 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer (Non-Small Cell)

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving two immunotherapy drugs — nivolumab and ipilimumab — before surgery (neoadjuvant) can shrink tumours and improve outcomes in patients with resectable (operable) non-small cell lung cancer. This is the GALAXY 3 trial, focusing specifically on patients with low or absent PD-L1 expression. **You may be eligible if...** - You are 18 or older - You have non-small cell lung cancer confirmed by biopsy that does not have EGFR or ALK mutations - Your cancer is at clinical stage II–IIIA and is suitable for surgery - Your PD-L1 expression is unknown or 1% or lower - You have not had any prior cancer treatment (surgery, chemotherapy, or radiation) **You may NOT be eligible if...** - You have an active autoimmune disease or history of severe autoimmune conditions - You have previously received treatment for this lung cancer or another malignancy - You have a known allergy to the study drugs - Your major organ function is compromised Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab & Ipilimumab

This 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.