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NCT07320105RecruitingPhase 4

Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)

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

Source: ClinicalTrials.gov · Last updated 6 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Dec 2025
Start date
15 Jan 2026
Primary completion date
15 Jan 2027
Lead sponsor
Fujian Cancer Hospital
Diseases
Lung cancer
NCT number
NCT07320105

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 60
  • From 15 Jan 2026 to the primary completion date, 15 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fujian Provincial Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.