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

January 28, 2026 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1811 combined with pertuzumab
Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab
Drug: SHR-A1811
Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS) by investigator assessment
Time Frame: Until progression, assessed up to approximately 2 years
Until progression, assessed up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate （ORR）
Time Frame: Two years after the last subject was enrolled in the group
Two years after the last subject was enrolled in the group
Overall Survival (OS)
Time Frame: Until death, assessed up to approximately 3 years
Until death, assessed up to approximately 3 years
Disease Control Rate (DCR)
Time Frame: Two years after the last subject was enrolled in the group
Two years after the last subject was enrolled in the group
Duration of Response (DOR)
Time Frame: Two years after the last subject was enrolled in the group
Two years after the last subject was enrolled in the group
AE
Time Frame: until to 90 days after the last dose，assessed up to approximately 3 years
until to 90 days after the last dose，assessed up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborators

Peking University Shenzhen Hospital
Maoming People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES-2025-235-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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