NCT06926790RecruitingPhase 2
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- First submitted
- 30 Mar 2025
- Start date
- 17 Feb 2025
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06926790
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 69
- From 17 Feb 2025 to the primary completion date, 31 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients have received other treatment for non-small cell lung cancer or for any other malignancy.
- Vaccination within 4 weeks prior to the start of the study.
Other illness
- Patients with active autoimmune disease or history of autoimmune disease.
- History of allergy to study drug components.
- Any mental or psychological condition that would prevent the patient from completing the study or understanding the patient information.
- Patients who have other malignancies.
- History of major surgery or serious injury within the past 3 months.
- HIV, HBV, HCV infection or active pulmonary tuberculosis.
- Presence of underlying medical conditions that, in the investigator's judgment, could increase the risk associated with study drug administration or interfere with the assessment of toxicity and adverse events.
Other
- Pregnant or breast-feeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.