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

Patients who meet the following criteria are enrolled:

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 Received SHR-A1811 combined with pertuzumab

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.