Induction Chemoimmunotherapy in Combination With Chemoradiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer

Inclusion criteria

• Age \>18 years, male or female, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
• Unresectable stage III NSCLC (according to the 8th edition of the AJCC staging system).
• No prior exposure to any other anti-tumor therapy.
• Absence of severe medical comorbidities or major organ dysfunction, as assessed by hematology, hepatic, renal, cardiac, and pulmonary function tests, meeting the following criteria: Hematology: Hemoglobin (HB) ≥ 90 g/L (without blood transfusion within 14 days prior to enrollment); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L. Biochemistry: Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum creatinine (Cr) ≤ 1 × ULN, with an endogenous creatinine clearance rate \> 60 mL/min (calculated using the Cockcroft-Gault formula). Coagulation: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is receiving anticoagulant therapy, in which case PT or aPTT must be within the expected therapeutic range for the anticoagulant used).
• Life expectancy ≥ 3 months.
• Adequate understanding of the study, ability to complete treatment, suitability for follow-up, and voluntary provision of written informed consent.

Exclusion criteria

• Presence of small cell carcinoma components in the histological examination results.
• Co-occurrence of EGFR mutation, ALK rearrangement, or ROS-1 rearrangement positivity.
• History of other primary malignancies, with the following exceptions: Malignancies treated with curative intent with no known active disease and low potential for recurrence for ≥5 years prior to the first dose of investigational product (IP); adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease.
• Active or documented history of autoimmune or inflammatory diseases (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[excluding diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, granulomatosis with polyangiitis \[Wegener's syndrome\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.).
• History of allogeneic organ transplantation.
• History of active primary immunodeficiency.
• Presence of uncontrolled concurrent illness, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus \[HIV\], etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), severe chronic gastrointestinal disease associated with diarrhea, or psychiatric disorders/social situations that would limit compliance with study requirements, substantially increase the risk of adverse events (AEs), or compromise the patient's ability to provide written informed consent.
• Female patients who are pregnant or breastfeeding.
• Concurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of induction immunotherapy. Exceptions include: intranasal, inhaled, or topical corticosteroids, or local corticosteroid injections (e.g., intra-articular injection); systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or its equivalent; corticosteroids as prophylactic premedication for hypersensitivity reactions (e.g., premedication for computed tomography \[CT\] scan); or systemic corticosteroid administration administered as part of chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC), or administered prophylactically or for the management of toxicity induced by chemotherapy and/or radiotherapy.
• Known allergy or hypersensitivity to any study drug or any excipient of a study drug.
• Patients judged by the investigator to be unable to comply with study procedures, restrictions, and requirements.