Post-surgery immunotherapy plus focal radiotherapy for NSCLC with multiple N2 lymph node metastases

Efficacy of Postoperative Radiotherapy in Patients With Multiple Postoperative N2 Metastases From Non-Small Cell Lung Cancer in the Immunotherapy Era: A Multicenter Prospective Controlled Phase II Clinical Trial

This trial will test whether adding the PD-1 drug tislelizumab (with standard platinum chemo), with or without focused radiotherapy, helps people 18–75 who had surgery for stage III NSCLC with multiple N2 lymph node metastases live longer without the cancer coming back.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07320105 on ClinicalTrials.gov

What this trial studies

This phase II study at Fujian Provincial Cancer Hospital enrolls patients who have undergone surgery for non-small cell lung cancer and have multiple (≥3) pathologically confirmed N2 lymph node metastases. Participants receive tislelizumab plus platinum-based chemotherapy, randomized or assigned to receive either systemic treatment alone or systemic treatment combined with focal postoperative radiotherapy. The main goal is to measure progression-free survival and safety, with overall survival as a secondary endpoint. All participants must meet performance status and organ-function criteria and be followed at the hospital for treatment and monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with pathologically confirmed NSCLC who, after surgery, have at least three N2 lymph node metastases, ECOG performance status 0–2, adequate organ function, and no prior chemo, radiotherapy, or immunotherapy.

Not a fit: Patients with active or prior autoimmune disease, known immunodeficiency (including HIV), prior systemic cancer therapy or radiotherapy, organ transplant history, severe cardiopulmonary dysfunction, or those outside the age or organ-function criteria are unlikely to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce the risk of recurrence and extend progression-free and possibly overall survival for high-risk post-surgical NSCLC patients with multiple N2 nodes.

How similar studies have performed: Adjuvant immunotherapy after chemotherapy has shown benefit in some resected NSCLC trials, but combining postoperative immunotherapy with focal radiotherapy for multiple N2 disease is a relatively novel approach without definitive proof yet.

Eligibility criteria

Inclusion Criteria:

* Age: ≥18 years old and ≤75 years old, no gender restriction; Pathologically (histologically or cytologically) confirmed non-small cell lung cancer with multiple N2 metastasis after surgery; No prior radiotherapy, chemotherapy or immunotherapy; At least 3 lymph node metastases confirmed by postoperative pathology; ECOG PS score: 0-2; Expected survival time ≥3 months; Normal major organ function, with basically normal results of blood routine, blood biochemistry and coagulation function tests; Basically normal immune indicators; No severe underlying diseases or severe cardiopulmonary dysfunction.

Exclusion Criteria:

* Known or suspected active autoimmune diseases, or history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); History of immunodeficiency (including positive HIV test), other acquired/congenital immunodeficiency diseases, organ transplantation or allogeneic 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 (e.g., NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmia); Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive anti-HCV and HCV-RNA above detection limit); Hereditary bleeding tendency or coagulation dysfunction; bleeding symptoms within 3 months, or positive fecal occult blood (++ or above); Toxicity from prior anti-tumor therapy not recovered to ≤CTCAE grade 1 (except alopecia); Known or suspected allergy to the study drug; Pregnant or lactating women; Subjects deemed unsuitable for inclusion by the investigator.

Where this trial is running

Fuzhou, Fujian

• Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Jiancheng Li, MD

Conditions Non-Small Cell Lung Cancer