A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

Inclusion Criteria: Males or females aged ≥18 to ≤75 years at the time of signing the ICF; Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy; EGFR-sensitive mutations; Failure of prior EGFR-TKI therapy; At least one measurable target lesion per RECIST 1.1 as assessed by the investigator; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Expected survival ≥12 weeks; Adequate organ and bone marrow function; Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures Exclusion Criteria: Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%; Other malignancies within 3 years prior to the first dose; History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis; Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed; Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria; Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; Prior TROP2-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs); Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study; Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study; Pregnant or lactating women;