Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC

March 31, 2026 updated by: Nanjing Tianyinshan Hospital

Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered Advanced/Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study

SHR-A1811 is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of SHR-A1811 used in Chinese lung cancer patients with HER2 alteration.

This real world, prospective study will assess the effectiveness and safety of SHR-A1811 in patients with locally advanced or metastatic, HER2-Altered NSCLC in real-world setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

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

Study Contact Backup

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

N/A

Sampling Method

Non-Probability Sample

Study Population

NSCLC patients with HER2 alteration who receiveSHR-A1811 based on physicians' discretion will be enrolled.

Description

Inclusion Criteria:

  • Age ≥18 years at signing informed consent form (ICF).
  • Pathologically documented unresectable and/or metastatic NSCLC.
  • Documented any known activating HER2 alteration.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  • Patients who receive SHR-A1811 based on physicians' discretion (Newly received or just have started the first dose no longer than 3 months before enrollment).

Exclusion Criteria:

  • Has spinal cord compression or clinically active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Treatment-related Adverse Events Graded ≥ 3
Time Frame: Baseline up to approximately 2 years
Baseline up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)
Time Frame: Baseline up to approximatley 2 years
Baseline up to approximatley 2 years
Overall Survival
Time Frame: Baseline up to approximately 2 years
Baseline up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Nanjing Tianyinshan Hospital

Collaborators

Henan Cancer 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)

April 10, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • E2026-009-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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