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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SHR-A1811

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Maoming People's Hospital

Collaborator

Peking University Shenzhen Hospital

Collaborator