Resectable non-small cell lung cancer
Conditions
Interventions
Test group:Sacituzumab tirumotecan in combination with Toripalimab
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, male or female. 2. ECOG performance status score of 0–1 within 7 days prior to dosing. 3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 4. Negative for EGFR sensitizing mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene. 5. No prior local therapy (surgery or radiotherapy) or any prior systemic anti-tumor therapy for NSCLC, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, traditional Chinese medicine, or any other investigational medicinal product. 6. Subjects with resectable stage II–IIIA NSCLC as assessed by MDT (according to the 8th edition of UICC/AJCC TNM staging system). 7. At least one measurable lesion per RECIST 1.1 criteria. 8. Patients who agree to undergo radical surgical treatment. 9. Surgically resectable and no contraindications to surgery as evaluated by a surgeon. 10. Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose). 11. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use effective medical contraceptive measures from the time of signing informed consent until 6 months after the last dose (see Appendix 2 for details). 12. Subjects are voluntarily enrolled in this study, have signed the informed consent form, and are able to comply with the scheduled visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed tumor with components of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma. 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or agents specifically targeting T-cell co-stimulation or checkpoint pathways. 3. Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitor therapy. 4. Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose and during the study (use of strong CYP3A4 inhibitors or inducers is not permitted in this study; representative agents of strong CYP3A4 inhibitors or inducers are listed in Appendix 6). All subjects must avoid concomitant use of any known CYP3A4-inducing medications, herbal supplements, and/or consumption of such foods as much as possible. 5. History of other malignancy within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin. 6. Known history of hypersensitivity to the study drug or its components, history of immunodeficiency, or history of organ transplantation. 7. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening. Severe pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (e.g., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc.), or prior pneumonectomy. 8. Active autoimmune disease requiring systemic therapy in the past 2 years (hormone replacement therapy is not considered systemic therapy, e.g., type 1 diabetes mellitus, hypothyroidism requiring only thyroxine replacement, adrenal or pituitary insufficiency requiring only physiological-dose glucocorticoid replacement). 9. Active infection requiring systemic therapy within 2 weeks prior to the first dose. 10. Active hepatitis B [positive hepatitis B surface antigen (HBsAg) with HBV-DNA testing required; HBV-DNA >= 500 IU/mL or above the lower limit of detection, whichever is higher] or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection). 11. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 12. Any severe concomitant disease that, in the investigator’s judgment, compromises patient safety or impairs the patient’s ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes mellitus, active infection, etc. 13. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that impairs delayed corneal healing. 14. Pregnant or lactating female. 15. Any condition that, in the investigator’s judgment, interferes with the evaluation of the study drug, subject safety, or interpretation of study results, or any other condition for which the investigator deems the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Major Pathological response;Event-Free Survival (EFS);Incidence and severity of adverse events;Objective response rate; | — |
Countries
China
Contacts
Public ContactJian Sun
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed