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NCT Number: NCT07516015

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

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.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No drug

Other

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.

Primary outcomes

  1. Incidence of Treatment-related Adverse Events Graded ≥ 3

    Time frame: Baseline up to approximately 2 years

Secondary outcomes

  1. Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)

    Time frame: Baseline up to approximatley 2 years

  2. Overall Survival

    Time frame: Baseline up to approximately 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Wenshu Qu

CONTACT

[email protected]

Yong Song

CONTACT

[email protected]

86 13851761392

Sponsors and collaborators

Lead sponsor

Nanjing Tianyinshan Hospital

Other

Collaborators

  • Henan Cancer Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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