This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.
Age ≥18 years at the time of informed consent signing, either sex;
ECOG performance status score of 0-1 within 7 days prior to dosing;
Histologically or cytologically confirmed NSCLC;
Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;
Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways;
Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors;
Requirement for strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to first dosing and during the study (strong CYP3A4 inhibitors or inducers are not permitted in this study; Appendix 6 lists representative drugs of strong CYP3A4 inhibitors or inducers); all subjects must avoid concomitant use of any drugs, herbal supplements, and/or foods known to induce CYP3A4.