Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC

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.