Lung Cancer - Non Small CellPhase 2GALAXY 3NCT06926790
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
A Phase 2 study testing Nivolumab & Ipilimumab in people with Lung Cancer - Non Small Cell, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer - Non Small Cell
- What is being tested?
- Nivolumab & Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to 31 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Shuben Li, PHD, +8613925810521, 13500030280@163.com
Jiawei Chen, PHD, +8613925810521, m13925810521@163.com
About this study
Official title: Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer
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.
Read the detailed description
Lung cancer remains the leading cause of cancer-related death globally. Neoadjuvant immunotherapy followed by surgery has been emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). Numerous clinical trials highlighted the efficacy of preoperative immunochemotherapy, including remarkably shrinking the primary lesion, eliminating micrometastases and ultimately contributing to survival outcomes. Notably, studies also demonstrated neoadjuvant immunochemotherapy increased the access of modified surgery and enhanced survival prognosis of patients with locally advanced NSCLC (IIIB).
Despite these advances, certain limitations remain. Conventional chemotherapy components may elevate treatment-related toxicity, particularly in elderly populations. Additionally, the efficacy of preoperative immunochemotherapy for patients with PD-L1<1% remained to be improve. Emerging evidences demonstrated that nivolumab (anti-PD-1) combine with ipilimumab (antiCTLA-4) provided superior response for the treatment of advanced NSCLC patients. 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. The study will enroll 69 eligible participants, with the primary endpoint being pathological complete response (pCR) rate following neoadjuvant therapy.
- Conditions
- Lung Cancer - Non Small Cell
- Being tested
- Nivolumab & Ipilimumab
- Keywords
- lung cancer, nivolumab plus ipilimumab, neoadjuvant treatment, non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab & IpilimumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nivolumab & Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (PCR)
Pathological complete response is predefined as no residual viable tumor cells in primary tumor and lymph nodes.
Measured: Within 2 weeks after surgery
Secondary outcomes (10)
3-year Event-Free Survival (3-year EFS）
The starting point for EFS was the initiation of neoadjuvant treatment. The endpoint for EFS was defined as the date of death, recurrence, progression, or the last follow-up.
Measured: From neoadjuvant treatment to the date of death, recurrence, progression, or the last follow-up (assessed up to 3 years).
Major Pathological Response (MPR)
Major pathological response defined as less than 10% of viable tumor cells in primary tumor.
Measured: Within 2 weeks after surgery
Safety (Rate of grade 3 and higher grade treatment-related adverse events (TRAEs))
Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Measured: Between the last dose of neoadjuvant treatment and surgery (assessed up to 30 days)
Radiological Response
Radiographic response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: Between the last dose of neoadjuvant treatment and surgery
Postoperative complications
Postoperative complications will be evaluated and recorded after the surgery following Clavien-Dindo grade. The minimum and maximum values were grade I-V, and the higher scores mean a worse outcomes.
Measured: After the surgery assess to 90 days
Intraoperative bleeding
Intraoperative bleeding was assessed and recorded by the surgical team. Blood loss was estimated by measuring suction canister volume and weighing surgical sponges, subtracting irrigation fluid.
Measured: Up to approximately 20 weeks
The Quality of Life
The quality of life will be evaluated and recorded according to the EORTC QLQ-C30. The minimum and maximum values were 0-100, and the higher scores mean a better outcome.
Measured: From the Day 1 to at least 90 days after surgery
Duration of surgery
Duration of surgery is the time spent in surgery.
Measured: Up to approximately 20 weeks
Hospital Stay
Hospital Stay is the length of inpatient time spent in hospital.
Measured: Up to approximately 20 weeks
Feasibility (Completion rate of neoadjuvant treatment and surgery)
Propotion of patients who complete neoadjuvant treatment and receive surgery within 42 days after neoadjuvant treatment
Measured: From date of treatment allocation until surgery, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start17 Feb 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer - Non Small CellStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuben Li, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926790
- Sponsor's protocol ID
- ES-2025-027-01
- Acronym
- GALAXY 3
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06926790
- Acronym / sponsor ID
- GALAXY 3 / ES-2025-027-01
- Conditions
- Lung Cancer - Non Small Cell
- Keywords
- lung cancer, nivolumab plus ipilimumab, neoadjuvant treatment, non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer remains the leading cause of cancer-related death globally. Neoadjuvant immunotherapy followed by surgery has been emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). Numerous clinical trials highlighted the efficacy of preoperative immunochemotherapy, including remarkably shrinking the primary lesion, eliminating micrometastases and ultimately contributing to survival outcomes. Notably, studies also demonstrated neoadjuvant immunochemotherapy increased the access of modified surgery and enhanced survival prognosis of patients with locally advanced NSCLC (IIIB).
Despite these advances, certain limitations remain. Conventional chemotherapy components may elevate treatment-related toxicity, particularly in elderly populations. Additionally, the efficacy of preoperative immunochemotherapy for patients with PD-L1<1% remained to be improve. Emerging evidences demonstrated that nivolumab (anti-PD-1) combine with ipilimumab (antiCTLA-4) provided superior response for the treatment of advanced NSCLC patients. 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. The study will enroll 69 eligible participants, with the primary endpoint being pathological complete response (pCR) rate following neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment | Experimental | Drug: Nivolumab & IpilimumabPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab & IpilimumabThis 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. | Drug | Neoadjuvant treatment |
Primary outcome
Pathological Complete Response (PCR)
Time frame: Within 2 weeks after surgery
Pathological complete response is predefined as no residual viable tumor cells in primary tumor and lymph nodes.
10 secondary outcomes
3-year Event-Free Survival (3-year EFS）
Time frame: From neoadjuvant treatment to the date of death, recurrence, progression, or the last follow-up (assessed up to 3 years).
Major Pathological Response (MPR)
Time frame: Within 2 weeks after surgery
Safety (Rate of grade 3 and higher grade treatment-related adverse events (TRAEs))
Time frame: Between the last dose of neoadjuvant treatment and surgery (assessed up to 30 days)
Radiological Response
Time frame: Between the last dose of neoadjuvant treatment and surgery
Postoperative complications
Time frame: After the surgery assess to 90 days
Intraoperative bleeding
Time frame: Up to approximately 20 weeks
The Quality of Life
Time frame: From the Day 1 to at least 90 days after surgery
Duration of surgery
Time frame: Up to approximately 20 weeks
Hospital Stay
Time frame: Up to approximately 20 weeks
Feasibility (Completion rate of neoadjuvant treatment and surgery)
Time frame: From date of treatment allocation until surgery, assessed up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab & Ipilimumab in people with Lung Cancer - Non Small Cell, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuben Li, Professor (020-8306-2114, 13500030280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (PCR) (time frame: Within 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.