Non-small cell lung cancer
Conditions
Interventions
Experimental arm:Sintilimab Combined with Sacituzumab tirumotecan
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study, are able to sign the informed consent form, and have good compliance; 2. Aged 18–75 years (at the time of signing the informed consent form), male or female; 3. Histologically confirmed stage IIA to IIIB (stage IIIB limited to T2/3/4N2) non-small cell lung cancer (staging based on the 9th edition of AJCC); 4. No prior local treatment (surgery or radiotherapy) for NSCLC or any prior systemic anti-tumor therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine therapy, or any other investigational drug therapy; 5. ECOG PS score of 0–1; 6. Expected survival time >= 3 months; 7. Subjects are required to provide archived tumor tissue samples (FFPE tissue blocks or approximately >= 6 newly cut unstained FFPE sections) and the pathological report of the baseline sample for PD-L1 and other biomarker analyses. If no archived samples are available or the samples are unavailable, a biopsy sample must be taken at baseline. 8. Sufficient organ and bone marrow function, with laboratory test results within 7 days before enrollment meeting the following requirements: Blood routine: Absolute neutrophil count (ANC) >= 1.5×10?/L, platelet (PLT) >= 75×10?/L, hemoglobin (HGB) >= 90 g/L (no blood transfusion or erythropoietin dependence within 14 days); Liver function: Serum total bilirubin (TBIL) = 45 mL/min/1.73 m²; Coagulation function: International normalized ratio (INR) or prothrombin time (PT) <= 1.5×ULN; 9. Evaluated by thoracic surgeons as meeting the requirements for R0 resection for the purpose of radical treatment; 10. Investigators assess measurable disease according to RECIST version 1.1; 11. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to take effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose; 12. Voluntarily participate in this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with a known history of central nervous system (CNS) metastasis; 2. Subjects with EGFR mutation or ALK translocation; 1) For patients with non-squamous cell carcinoma, tumor tissue-based EGFR test results must be provided. If the EGFR mutation status is unknown, EGFR testing must be performed before enrollment. 2) For patients with squamous non-small cell lung cancer, if the EGFR mutation status is unknown, testing is not required during screening. 3) For patients with unknown ALK fusion gene status (regardless of non-squamous or squamous cell carcinoma), testing is not required. 3. Previous treatment with TROP2-targeted therapy and/or topoisomerase I inhibitor therapy; 4. Previous treatment with immune checkpoint inhibitors, including but not limited to anti-cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4), anti-PD-1, anti-PD-L1 therapeutic antibodies, and OX-40; 5. Currently participating in an interventional clinical trial, or having received other investigational drugs or medical interventions within 4 weeks; 6. Known history of allergy to the drugs in this protocol or their components; 7. A history of active autoimmune diseases requiring systemic treatment or potentially recurrent autoimmune diseases; 8. Patients requiring long-term systemic use of glucocorticoids (patients requiring inhaled or local injectable glucocorticoids for COPD or asthma may be enrolled), or patients who have received immunosuppressive therapy within 7 days before treatment; 9. Active infection requiring treatment or systemic anti-infective drugs used within one week before the first dose; 10. A history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.; 11. Known history of human immunodeficiency virus (HIV) infection, untreated active hepatitis B (defined as positive HBsAg with detectable HBV-DNA copy number > 2000 IU/ml), and subjects with active hepatitis C infection (positive HCV antibody and HCV-RNA level above the lower limit of detection); 12. Previous allogeneic stem cell transplantation or organ transplantation; 13. Vaccination with live vaccines within 30 days before the first dose (Cycle 1, Day 1); 14. Pregnant or lactating women; 15. Any condition that the investigator deems may interfere with the evaluation of the study drug, the safety of the subject, or the interpretation of study results, or other conditions that the investigator deems inappropriate for the subject to participate in this study..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) Rate;Event-Free Survival (EFS);Overall Survival (OS);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactWang Jian
Department of Thoracic Surgery,Tangdu Hospital, Air Force Military Medical University
Outcome results
None listed