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.
Single group
Sacituzumab Govitecan (SG)+Toripalimab
Drug1. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle. 2. Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle.
Pathological Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Overall Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 before surgery.
Radiological downstaging rate
The proportion of patients with radiological T, N, and overall stage reduction (AJCC v9) compared to baseline after neoadjuvant therapy.
Major Pathological Response (mPR) Rate
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Event Free Survival (EFS)
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
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