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Recruiting

NCT Number: NCT07320105

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

Location status: Recruiting

Location contact

Jiancheng Li, MD

CONTACT

[email protected]

+86-13906900190

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab + platinum-based chemotherapy

Drug

Tislelizumab (200mg IV every 3 weeks) combined with platinum-based chemotherapy (postoperative adjuvant regimen).

Tislelizumab + platinum-based chemotherapy + focal radiotherapy

Drug

Tislelizumab + platinum-based chemotherapy (same as above) plus focal radiotherapy (50Gy total dose to the lesion).

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Every 3 months, up to 24 months after randomization

    The time from randomization to the first occurrence of disease progression (per RECIST 1.1 criteria) or death from any cause; assessed every 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiancheng Li, MD

CONTACT

[email protected]

+86-13906900190

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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