NCT07516015Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 10 Apr 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Nanjing Tianyinshan Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07516015
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 10 Apr 2026 to the primary completion date, 30 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.