Clinical trial · Interventional
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer - Non Small Cell | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab & Ipilimumab | Drug | Ipilimumab/Nivolumab Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant treatment
- description
- Patients with IIA-IIIB NSCLC will received 2-3 cycles of neoadjuvant Nivolumab (3 mg/kg intravenously (i.v.), every 3 week) plus Ipilimumab (1 mg/kg i.v., every 6 week). Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy. After the second cycles treatment, contrast-enhanced chest CT will be performed to evaluate the tumor.
- interventionNames
- Drug: Nivolumab & Ipilimumab
Primary outcomes (1)
- measure
- Pathological Complete Response (PCR)
- timeFrame
- Within 2 weeks after surgery
- description
- Pathological complete response is predefined as no residual viable tumor cells in primary tumor and lymph nodes.
Secondary outcomes (10)
- measure
- 3-year Event-Free Survival (3-year EFS）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 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.
References
Publications (0)
Data not yet available