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
Locations
Sponsors and collaborators
The First Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Maoming People's Hospital
Collaborator
Peking University Shenzhen Hospital
Collaborator