Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

NCT06926790 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ES-2025-027-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer - Non Small Cell

Keywords

lung cancer; nivolumab plus ipilimumab; neoadjuvant treatment; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (PCR)

  Pathological complete response is predefined as no residual viable tumor cells in primary tumor and lymph nodes.

  Within 2 weeks after surgery

Secondary Outcomes (10)

• 3-year Event-Free Survival (3-year EFS）

  From neoadjuvant treatment to the date of death, recurrence, progression, or the last follow-up (assessed up to 3 years).

• Major Pathological Response (MPR)

  Within 2 weeks after surgery

• Safety (Rate of grade 3 and higher grade treatment-related adverse events (TRAEs))

  Between the last dose of neoadjuvant treatment and surgery (assessed up to 30 days)

• Radiological Response

  Between the last dose of neoadjuvant treatment and surgery

• Postoperative complications

  After the surgery assess to 90 days

Study Arms (1)

Neoadjuvant treatment

EXPERIMENTAL

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.

Drug: Nivolumab & Ipilimumab

Interventions

Nivolumab & Ipilimumab DRUG

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.

Neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with active autoimmune disease or history of autoimmune disease.
• Patients have received other treatment for non-small cell lung cancer or for any other malignancy.
• History of allergy to study drug components.
• Pregnant or breast-feeding.
• 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.
• Vaccination within 4 weeks prior to the start of the study.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shuben Li, Professor

CONTACT

020-8306-2114; 13500030280@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Training Program of Thoracic Surgery, Director, Section of Tracheal and Pulmonary Surgery, Thoracic Surgery Department

Model Details: Patients with IIA-IIIB NSCLC received neoadjuvant Nivolumab (3 mg/kg intravenously (i.v.), every 3 week) plus Ipilimumab (1 mg/kg i.v., every 6 week).

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 15, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: April 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)