NSCLCNCT07516015
Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC
An observational study of NSCLC, run by Nanjing Tianyinshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- No Drug
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: NSCLC patients with HER2 alteration who receiveSHR-A1811 based on physicians' discretion will be enrolled.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Wenshu Qu contact
About this study
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
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.
- Conditions
- NSCLC
- Being tested
- No Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrugOther
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 is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events Graded ≥ 3
Measured: Baseline up to approximately 2 years
Secondary outcomes (2)
Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)
Measured: Baseline up to approximatley 2 years
Overall Survival
Measured: Baseline up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Tianyinshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516015
- Sponsor's protocol ID
- E2026-009-01
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07516015
- Acronym / sponsor ID
- E2026-009-01
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanjing Tianyinshan HospitalUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients with HER2 alteration who receiveSHR-A1811 based on physicians' discretion will be enrolled.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No DrugThis 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. | Other | – |
Primary outcome
Incidence of Treatment-related Adverse Events Graded ≥ 3
Time frame: Baseline up to approximately 2 years
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenshu Qu contact
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Nanjing Tianyinshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Song (86 13851761392, yong.song@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events Graded ≥ 3 (time frame: Baseline up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.