Actively Recruiting
Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)
Led by Fujian Cancer Hospital · Updated on 2026-01-06
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be conducted at Fujian Provincial Cancer Hospital. Its main goals are to evaluate the progression-free survival (PFS) and safety of postoperative immunotherapy combined with radiotherapy in patients with high-risk stage Ⅲ N2 non-small cell lung cancer after surgery. It will also assess the overall survival (OS) of this treatment as a secondary goal. This study has been approved by the Medical Ethics Committee of Fujian Provincial Cancer Hospital, and the rights and safety of all participants will be fully protected during the trial.
CONDITIONS
Official Title
Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Pathologically confirmed non-small cell lung cancer with multiple N2 metastases after surgery
- No prior radiotherapy, chemotherapy, or immunotherapy
- At least 3 lymph node metastases confirmed by postoperative pathology
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2
- Expected survival time of at least 3 months
- Normal major organ function with essentially normal blood routine, blood biochemistry, and coagulation test results
- Basically normal immune indicators
- No severe underlying diseases or severe cardiopulmonary dysfunction
You will not qualify if you...
- Known or suspected active autoimmune diseases or history of autoimmune diseases such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism
- History of immunodeficiency including positive HIV test, other acquired or congenital immunodeficiency diseases, organ or bone marrow transplantation
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, symptomatic active pneumonia, or severe pulmonary dysfunction
- Poorly controlled cardiovascular symptoms or diseases such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, or uncontrolled arrhythmia
- Active hepatitis B with high viral load or active hepatitis C infection
- Hereditary bleeding tendency or coagulation dysfunction, bleeding symptoms within 3 months, or positive fecal occult blood test (grade ++ or above)
- Toxicity from prior anti-tumor therapy not recovered to CTCAE grade 1 or better (except alopecia)
- Known or suspected allergy to the study drug
- Pregnant or lactating women
- Subjects deemed unsuitable for inclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
Research Team
J
Jiancheng Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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