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

Starting soon · Not applicable

Conditions studied: Non-Small Cell Lung Cancer

In brief

The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.

Key facts

Study ID

NCT07377916

Run by

The First Affiliated Hospital of Guangzhou Medical University

People needed

60

Starts

2026-02-15

Expected to finish

2029-12-31

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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