Status:
RECRUITING
Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Lung Cancer - Non Small Cell
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 component...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2030
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06926790
Start Date
February 17 2025
End Date
October 31 2030
Last Update
April 22 2025
Active Locations (1)
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1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510120