The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.
Male or female, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF).
Histologically or cytologically confirmed NSCLC.
No prior systemic anti-tumor therapy.
No prior local therapy for NSCLC.
Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%.
Participants with other malignant tumors within 3 years prior to randomization.
Resting electrocardiogram (ECG) showing clinically significant abnormal results.
Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
Single group
Sacituzumab Tirumotecan
DrugSacituzumab Tirumotecan: 4mg/kg, intravenous (IV) infusion
Osimertinib
Drug80mg, QD
Major Pathological Response (MPR) rate
MPR rate is defined as the proportion of participants achieving ≤ 10% residual viable tumor cells in the postoperative surgical specimen.
pathological Complete Response (pCR) rate
pCR rate is defined as the proportion of participants achieving absence of any residual viable tumor cells in the postoperative surgical specimen.
Residual viable tumor percentage (RVT%)
RVT% is defined as the proportion of residual viable tumor cells in the postoperative surgical specimen.
R0 resection rate
Proportion of participants achieving R0 resection
Pathological lymph node downstaging rate
Pathological lymph node downstaging rate is defined as the proportion of participants achieving pathological lymph node downstaging
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