Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer

Exclusion Criteria

• •Inability to comply with the research protocol or study procedures.
• •Previous receipt of any treatment, including chemotherapy or radiotherapy, for the currently diagnosed lung cancer.
• •Patients with positive driver gene mutations such as EGFR, ALK, or ROS1.
• •History of allergy or hypersensitivity to the investigational drug(s) or any of their excipients, or a history of atopy.
• •Presence of active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs indicating severe pulmonary impairment during the screening period.
• •Concurrent severe cardiovascular or cerebrovascular diseases.
• •Receipt of broad-spectrum antibiotic therapy via any route within 30 days prior to the first dose.
• •Positive anti-HIV test; positive Hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal (ULN); active Hepatitis C virus (HCV) infection.
• •Evident bleeding tendency or other significant evidence of coagulation disorders.
• •Current interstitial pneumonia or interstitial lung disease, or a prior history of interstitial pneumonia or interstitial lung disease requiring corticosteroid treatment; or other conditions such as pulmonary fibrosis or organizing pneumonia that may interfere with the assessment and management of immune-related pulmonary toxicity.
• •Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage (except for cases with only minimal ascites visible on imaging without clinical symptoms), or uncontrolled or moderate-to-large pleural effusion or pericardial effusion.
• •Ongoing systemic corticosteroid therapy or other immunosuppressive agents within 14 days prior to the first dose, or use of immunostimulants (including but not limited to interferon or interleukin-2) within 4 weeks prior.
• •Diagnosis of other malignancies within 5 years prior to enrollment, except for radically resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix.
• •Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment.
• •Patients deemed by the investigator to be unsuitable for participation in this study.