Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered Advanced/Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study
Observational study on SHR-A1811 for HER2-altered lung cancer in China
Plain English Summary
Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC is a Not Applicable clinical trial sponsored by Nanjing Tianyinshan Hospital studying NSCLC. This study will look at how well SHR-A1811 works and how safe it is for lung cancer patients in China with a specific genetic change (HER2 alteration). It's for adult patients in China with advanced or spreading non-small cell lung cancer (NSCLC) that has a HER2 alteration. Participation involves being observed while receiving SHR-A1811 as decided by your doctor. No new drug is given as part of this study. Alternative treatments may include other targeted therapies or chemotherapy, depending on your doctor's recommendation and your specific cancer. The trial aims to enroll 1000 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread. Patients must have a known HER2 genetic change in their cancer. Individuals should have a good general health status (ECOG performance status 0-2) and have started or will start SHR-A1811 within 3 months of enrollment. People with active brain metastases, spinal cord compression, or uncontrolled serious medical conditions cannot join. This trial is studying NSCLC, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will track serious side effects related to the treatment to understand how safe SHR-A1811 is in a real-world setting for these patients. The specific primary outcome measures are: Incidence of Treatment-related Adverse Events Graded ≥ 3 (Baseline up to approximately 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This study is important because it will provide real-world data on SHR-A1811, a drug already approved in China, for a specific group of lung cancer patients with HER2 alterations, filling a gap in cur This research targets NSCLC, where improved treatment options are needed.
Investor Insight
This observational study on an approved drug in a large market like China signals continued interest and the need for real-world evidence to support its use, potentially strengthening its market posit The large enrollment target of 1000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if SHR-A1811 is the right treatment for your specific type of lung cancer and if this study is a good fit for you. Understand that this is an observational study, meaning your treatment decisions are made by your doctor, and the study will collect information about your progress and any side effects. Be prepared for regular follow-up appointments to monitor your health and treatment response. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 1,000 participants
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 Outcomes
- Incidence of Treatment-related Adverse Events Graded ≥ 3 (Baseline up to approximately 2 years)
Secondary Outcomes
- 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)
Full 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.
Frequently Asked Questions
What is clinical trial NCT07516015?
NCT07516015 is a Not Applicable OBSERVATIONAL study titled "Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC." It is currently not yet recruiting and is sponsored by Nanjing Tianyinshan Hospital. The trial targets enrollment of 1000 participants.
What conditions does NCT07516015 study?
This trial investigates treatments for NSCLC. The primary condition under study is NSCLC.
What treatments are being tested in NCT07516015?
The interventions being studied include: 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.
What does Not Applicable mean for NCT07516015?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07516015?
This trial is currently "Not Yet Recruiting." It started on 2026-04-10. The estimated completion date is 2029-12-31.
Who is sponsoring NCT07516015?
NCT07516015 is sponsored by Nanjing Tianyinshan Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07516015?
The trial aims to enroll 1000 participants. The trial has not yet started recruiting.
How is NCT07516015 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07516015?
The primary outcome measures are: Incidence of Treatment-related Adverse Events Graded ≥ 3 (Baseline up to approximately 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07516015?
The official record for NCT07516015 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07516015. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07516015 testing in simple terms?
This study will look at how well SHR-A1811 works and how safe it is for lung cancer patients in China with a specific genetic change (HER2 alteration). It's for adult patients in China with advanced or spreading non-small cell lung cancer (NSCLC) that has a HER2 alteration.
Why is this trial significant?
This study is important because it will provide real-world data on SHR-A1811, a drug already approved in China, for a specific group of lung cancer patients with HER2 alterations, filling a gap in cur
What are the potential risks of participating in NCT07516015?
The most common risks are side effects from SHR-A1811, which can include nausea, fatigue, and skin reactions. More serious side effects, graded as severe (Grade 3 or higher), will be closely monitored, and could include issues like liver problems or lung inflammation. It's important to report any new or worsening symptoms to your doctor immediately. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07516015?
Ask your doctor if SHR-A1811 is the right treatment for your specific type of lung cancer and if this study is a good fit for you. Understand that this is an observational study, meaning your treatment decisions are made by your doctor, and the study will collect information about your progress and any side effects. Be prepared for regular follow-up appointments to monitor your health and treatment response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07516015 signal from an investment perspective?
This observational study on an approved drug in a large market like China signals continued interest and the need for real-world evidence to support its use, potentially strengthening its market posit This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being observed while receiving SHR-A1811 as decided by your doctor. No new drug is given as part of this study. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.