In recent years, substantial progress has been made in the development of perioperative immunotherapy for non-small cell lung cancer (NSCLC). Accumulating evidence indicates that both neoadjuvant and adjuvant immunotherapy can significantly enhance key clinical endpoints, including pathological response rate, event-free survival (EFS), and disease-free survival (DFS), particularly in patients with stage II-III NSCLC. However, in the subset of patients with resectable stage II-IIIB NSCLC, the pathological complete response (pCR) rate following neoadjuvant immunotherapy remains modest at approximately 17-25%, underscoring the need for more effective therapeutic strategies and novel combination regimens. TROP2-targeted antibody-drug conjugates (TROP2-ADCs) have demonstrated promising antitumor activity and a manageable safety profile in patients with previously treated advanced NSCLC. Furthermore, the combination of Sacituzumab tirumotecan and tagitanlimab has shown robust efficacy in the first-line treatment of PD-L1-positive (tumor proportion score \[TPS\] ≥ 1%), driver gene-negative advanced NSCLC, with an objective response rate (ORR) exceeding 80%. Based on these encouraging data, we designed this study to evaluate the efficacy and safety of Sacituzumab tirumotecan in combination with tagitanlimab as neoadjuvant therapy in patients with PD-L1-positive (TPS ≥ 1%), resectable stage II-IIIB NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Patients will receive 4 cycles of neoadjuvant treatment with preoperative Sacituzumab tirumotecan in combination with tagitanlimab, followed by surgery. After surgery, patients will receive up to 13 cycles of adjuvant tagitanlimab.
Pathological Complete Response
0% residual viable tumor cells in the primary tumor and sampled lymph nodes
Time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
Major Pathological Response
Major Pathological Response (≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes)
Time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
R0 Resection Rate
The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.
Time frame: Pre-operation
Objective Response Rate (ORR)
Defined as the proportion of patients whose tumor size shrinks to predefined values,which including cases of CR and PR. Objective tumor response will be assessed using RECIST 1.1. Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1.
Time frame: 1 month after surgery
Event-free survival(EFS)
Defined as the time from treatment initiation to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause, assessed according to RECIST v1.1.
Time frame: Up to 24 months
Overall survival (OS)
Defined as the time from the initiation of study protocol treatment to the subject's death from any cause.
Time frame: Up to 5 years
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed
Time frame: From date of treatment allocation until surgery or within 30 days after last dose of preoperative treatment
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