Newly diagnosed non-small cell lung cancer confirmed by histology or cytology, with clinical stage II–IIIB, and considered surgically resectable.
Conditions
Interventions
Intervention group:Neoadjuvant therapy stage: Adbelimab (1200mg) combined with platinum-based dual-drug chemotherapy regimen, administered once every 3 weeks for 3 consecutive cycles, and on this basi
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and =10 mm (except for lymph nodes, which must have a short axis >=15 mm) on baseline computed tomography (CT) or magnetic resonance imaging (MRI), and suitable for reproducible and accurate measurement. 6. Adequate organ and bone marrow function reserve, with major organ function within normal limits, meeting the following criteria: (1) Routine laboratory results (within 14 days without blood transfusion): 1) Hemoglobin >=100 g/L; 2) Absolute neutrophil count (ANC) >=1.5×10^9/L; 3) Platelet count (PLT) >=80×10^9/L; (2) Liver and renal function parameters, including total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr), etc., within the normal reference range; (3) For patients not receiving anticoagulant therapy: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) <=1.5×ULN. 7. Subjects with good compliance, voluntarily participating in the study and signing the informed consent form. 8. For females or males of childbearing potential: effective contraceptive measures must be used during treatment, within 5 months after the last dose of immunotherapy, and within 6 months after the last dose of chemotherapy to avoid pregnancy or embryonic drug exposure. Female subjects must not donate ova during this period, and male subjects must not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. Histological or cytopathological diagnosis of mixed non-small cell lung cancer or small cell lung cancer. 2. Unresectable non-small cell lung cancer beyond stage IIIB. 3. Cardiac: LVEF 2000 IU/mL). 7. HIV/AIDS (CD4+ 10 mg prednisone equivalent/day); history of allergy to PD-1/PD-L1 inhibitors or chemotherapeutic agents. 13. History of allergy to taxanes, platinum agents, pemetrexed, nintedanib, adebrelimab, or their excipients. 14. Surgical feasibility: FEV1 35 mmHg). 15. Psychiatric or compliance barriers: inability to sign informed consent or complete follow-up. 16. Concurrent participation in other interventional studies. 17. Prior allogeneic stem cell or solid organ transplantation. 18. History of interstitial lung disease, drug-induced interstitial lung disease, or active interstitial pneumonia requiring systemic corticosteroids or immunosuppressive therapy. 19. Severe infection within 4 weeks before the start of study treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia. 20. Uncontrolled blood pressure (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg) or urine protein >=++ on routine urinalysis confirmed by 24-hour urine protein quantification >1.0 g. 21. Imaging shows tumor invasion of major vessels, or in the investigator's judgment, the tumor is highly likely to invade major vessels during the subsequent study period, potentially causing fatal massive hemorrhage. 22. Subjects who, in the investigator's opinion, may not be able to complete this study or comply with its requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| One-year OS;The incidence of surgery-related complications;R0 resection rate;One - year LRFS ;One-year DFS;Major Pathological Response Rate (MPR);Adverse events; | — |
Countries
China
Contacts
Public ContactNa Feifei
West China Hospital of Sichuan University
Outcome results
None listed