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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07516015

Enrollment

1000

Registered

2026-04-07

Start date

2026-04-10

Completion date

2029-12-31

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Brief summary

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.

Interventions

OTHERNo Drug

This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on SHR-A1811 will be enrolled in this study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Contacts

CONTACTYong Song

yong.song@nju.edu.cn86 13851761392

CONTACTWenshu Qu

quws1980@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026