A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy

Exclusion criteria

• ✕. For NSCLC, histologically or cytologically confirmed squamous cell carcinoma component or presence of coexisting small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma component;
• ✕. Known presence of meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active brain metastases;
• ✕. Prior treatment with systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib;
• ✕. Prior treatment with any TROP2-targeted therapy or any therapy that targets topoisomerase I (including ADCs);
• ✕. Other malignancies (except cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to enrollment;
• ✕. Presence of any of the following cardiovascular and cerebrovascular diseases or risk factors:
• ✕. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Class III or IV heart failure \[according to New York Heart Association (NYHA) classification\], symptomatic or poorly controlled serious arrhythmia, cerebrovascular accident, transient ischemic attack, and other serious cardiovascular and cerebrovascular diseases within 6 months prior to enrollment;
• ✕. Previous history of myocardial diseases such as myocarditis, primary cardiomyopathy and specific cardiomyopathy;