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

Starting soon

Conditions studied: NSCLC

In brief

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.

Key facts

Study ID

NCT07516015

Run by

Nanjing Tianyinshan Hospital

People needed

1000

Starts

2026-04-10

Expected to finish

2029-12-31

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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