AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

RecruitingPhase 2Ages 18 Years - 80 YearsAllThe First Affiliated Hospital of Guangzhou Medicaโ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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 malignancies. 7. History of major surgery or serious injury within the past 3 months. 8. HIV, HBV, HCV infection or active pulmonary tuberculosis. 9. Vaccination within 4 weeks prior to the start of the study. 10. 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.
๐Ÿ’Š

What it tests

  • Nivolumab & Ipilimumab
๐Ÿ“

Where

1 site
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy