Clinical Research Directory

Inclusion Criteria: * Aged 18-75 years * Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) * Pathologically documented HER2 mutation, amplification, or overexpression * Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease * There is at least one measurable lesion according to RECIST V1.1 criteria * ECOG score of 0 or 1. * The expected survival is ≥12 weeks Exclusion Criteria: * There are untreated or active central nervous system (CNS) tumor metastases * Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. * Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration * Systemic antitumor therapy was performed 4 weeks prior to study initiation * Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload. * Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose. * Has active infection requiring systemic treatment.