Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Drug.
- Who it may be relevant to
- Registry conditions: NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Other No 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.
Primary outcome measures
- Incidence of Treatment-related Adverse Events Graded ≥ 3 [Time frame: Baseline up to approximately 2 years]
Secondary outcome measures (2)
- Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS) [Time frame: Baseline up to approximatley 2 years]
- Overall Survival [Time frame: Baseline up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07516015 · E2026-009-01