A Randomized, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib or as Monotherapy for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy 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.
• Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• At least one target lesion as assessed by the investigator according to RECIST v1.1.
• Life expectancy ≥ 24 weeks.
• Adequate organ and bone marrow function.
⁃ For female participants of childbearing potential and male participants with partners of childbearing potential, they must agree to use effective medical contraception from the start of signing the ICF until 6 months after the last dose.
⁃ Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures.