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

Guangzhou Medical University

Status

Begins enrollment this month

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: SHR-A1811

Study type

Interventional

Funder types

Other

Identifiers

NCT07377916

ES-2025-235-02

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.