NCT07377916Not yet recruiting
Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC
A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 15 Feb 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07377916
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Feb 2026 to the primary completion date, 30 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Has active infection requiring systemic treatment.
Other
- There are untreated or active central nervous system (CNS) tumor metastases
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.