HER2-mutant Advanced Non-Small Cell Lung CancerNCT07880353
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
An observational study of HER2-mutant Advanced Non-Small Cell Lung Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a single-center, observational, bidirectional cohort study evaluating the real-world effectiveness, safety, and quality of life associated with sevabertinib in Chinese adults with HER2-mutant advanced non-small cell lung cancer receiving sevabertinib as second-line or later-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-mutant Advanced Non-Small Cell Lung Cancer
- What is being tested?
- Sevabertinib
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 30 Sep 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult Chinese patients with unresectable locally advanced or metastatic non-squamous NSCLC harboring a documented HER2 (ERBB2) TKD activating mutation who receive sevabertinib as second-line or later-line therapy in routine clinical practice. The study includes both retrospectively identified patients and prospectively enrolled patients.
Who may be able to join
- Age ≥18 years at the index date.
- Unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
- Documented HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutation.
- Received at least one prior systemic therapy for advanced NSCLC. Prior HER2-targeted antibody-drug conjugate (ADC) therapy is permitted, whereas prior HER2-targeted tyrosine kinase inhibitor (TKI) therapy is not permitted.
- For retrospectively included participants, sufficient baseline clinical, treatment, and prior follow-up data are available.
- Sevabertinib treatment has been determined by the treating physician based on clinical practice, or the participant has already initiated sevabertinib at screening.
Who cannot join
- History of Grade 3 or higher interstitial lung disease (ILD), or evidence of any clinically active ILD.
- Uncontrolled comorbid diseases or conditions, including but not limited to decompensated respiratory, cardiac, hepatic, or renal disease; ongoing or active infection, including active clinical tuberculosis; renal transplantation; or psychiatric/social conditions that may limit study compliance.
- Unstable brain metastases.
- Inability to comply with the study for any reason.
- Receipt of another unapproved investigational drug or non-drug treatment within 30 days before the index date or during the observation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan, 571400
Yi XIANG, +86-13816967846, xiangyiht@163.com
About this study
Official title: Real-World Efficacy and Safety of Sevabertinib as Second-Line or Later-Line Therapy in Patients With HER2-Mutant Advanced Non-Small Cell Lung Cancer: An Observational, Bidirectional Cohort Study
This is a single-center, observational, bidirectional cohort study evaluating the real-world effectiveness, safety, and quality of life associated with sevabertinib in Chinese adults with HER2-mutant advanced non-small cell lung cancer receiving sevabertinib as second-line or later-line therapy. The study will include both retrospectively identified patients and prospectively enrolled patients. The primary objective is to evaluate real-world progression-free survival. Additional assessments include tumor response, overall survival, safety, and patient-reported quality of life.
- Being tested
- Sevabertinib
- Keywords
- HER2-mutant, NSCLC, Sevabertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevabertinibDrug
Sevabertinib is administered as part of routine clinical care, generally at a dose of 20 mg orally twice daily with food until disease progression or unacceptable toxicity, according to the treating physician's clinical judgment. Treatment is not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Sevabertinib-Treated Cohort | Adult Chinese patients with HER2-mutant advanced non-small cell lung cancer receiving sevabertinib as second-line or later-line therapy in routine clinical practice. Treatment with sevabertinib is determined by the treating physician and is not assigned by the study protocol. Receives: Drug: Sevabertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-World Progression-Free Survival (rwPFS)
rwPFS is defined as the time from the first dose of sevabertinib to the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the first dose of sevabertinib until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.
Secondary outcomes (7)
Investigator-Assessed Real-World Objective Response Rate (rwORR)
rwORR is defined as the proportion of evaluable participants whose best overall response is complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1.
Measured: From the first dose of sevabertinib through the last available tumor response assessment, up to 12 months.
Investigator-Assessed Real-World Disease Control Rate (rwDCR)
rwDCR is defined as the proportion of evaluable participants who achieve CR, PR, or stable disease (SD). Confirmed and unconfirmed best overall responses will be analyzed separately.
Measured: From the first dose of sevabertinib through the last available tumor response assessment, up to 12 months.
6-Month and 12-Month Progression-Free Survival Rates
The probabilities of participants being alive and free from disease progression at 6 months and 12 months after the first dose of sevabertinib.
Measured: At 6 months and 12 months after the first dose of sevabertinib.
Incidence of Treatment-Related Adverse Events
The incidence of treatment-related adverse events of any grade and Grade 3 or higher will be assessed. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0.
Measured: From the first dose of sevabertinib through the last available safety assessment, up to 12 months.
Change From Baseline in EORTC QLQ-C30 Scores
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses cancer-related quality of life. Scores for each scale range from 0 to 100. Higher functional and global health status/quality-of-life scores indicate better functioning or quality of life, whereas higher symptom scores indicate worse symptoms.
Measured: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
Change From Baseline in NSCLC-SAQ Total Score
The Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) assesses NSCLC-related symptoms. The total score ranges from 0 to 20, with higher scores indicating greater symptom severity.
Measured: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
Change From Baseline in EQ-5D-5L Index Score
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) assesses overall health status across five dimensions. Using the Chinese value set, index scores range from -0.391 to 1.000, with higher scores indicating better health status.
Measured: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start20 Oct 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-mutant Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880353
- Sponsor's protocol ID
- RWS2026-003
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared with external researchers because the study uses sensitive clinical data derived from medical records and follow-up. Study data are de-identified and managed under applicable confidentiality, privacy, and institutional data security requirements, with access restricted to authorized study personnel.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Efficacy and Safety of Sevabertinib as Second-Line or Later-Line Therapy in Patients With HER2-Mutant Advanced Non-Small Cell Lung Cancer: An Observational, Bidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT07880353
- Acronym / sponsor ID
- RWS2026-003
- Keywords
- HER2-mutant, NSCLC, Sevabertinib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Oct 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.
This is a single-center, observational, bidirectional cohort study evaluating the real-world effectiveness, safety, and quality of life associated with sevabertinib in Chinese adults with HER2-mutant advanced non-small cell lung cancer receiving sevabertinib as second-line or later-line therapy. The study will include both retrospectively identified patients and prospectively enrolled patients. The primary objective is to evaluate real-world progression-free survival. Additional assessments include tumor response, overall survival, safety, and patient-reported quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevabertinib-Treated Cohort | – | Drug: SevabertinibAdult Chinese patients with HER2-mutant advanced non-small cell lung cancer receiving sevabertinib as second-line or later-line therapy in routine clinical practice. Treatment with sevabertinib is determined by the treating physician and is not assigned by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Chinese patients with unresectable locally advanced or metastatic non-squamous NSCLC harboring a documented HER2 (ERBB2) TKD activating mutation who receive sevabertinib as second-line or later-line therapy in routine clinical practice. The study includes both retrospectively identified patients and prospectively enrolled patients.
Key inclusion criteria (6 listed)
- Age ≥18 years at the index date.
- Unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
- Documented HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutation.
- Received at least one prior systemic therapy for advanced NSCLC. Prior HER2-targeted antibody-drug conjugate (ADC) therapy is permitted, whereas prior HER2-targeted tyrosine kinase inhibitor (TKI) therapy is not permitted.
- For retrospectively included participants, sufficient baseline clinical, treatment, and prior follow-up data are available.
Key exclusion criteria (5 listed)
- History of Grade 3 or higher interstitial lung disease (ILD), or evidence of any clinically active ILD.
- Uncontrolled comorbid diseases or conditions, including but not limited to decompensated respiratory, cardiac, hepatic, or renal disease; ongoing or active infection, including active clinical tuberculosis; renal transplantation; or psychiatric/social conditions that may limit study compliance.
- Unstable brain metastases.
- Inability to comply with the study for any reason.
- Receipt of another unapproved investigational drug or non-drug treatment within 30 days before the index date or during the observation period.
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 |
|---|---|---|
| SevabertinibSevabertinib is administered as part of routine clinical care, generally at a dose of 20 mg orally twice daily with food until disease progression or unacceptable toxicity, according to the treating physician's clinical judgment. Treatment is not assigned by the study protocol. | Drug | Sevabertinib-Treated Cohort |
Primary outcome
Real-World Progression-Free Survival (rwPFS)
Time frame: From the first dose of sevabertinib until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.
rwPFS is defined as the time from the first dose of sevabertinib to the first documented disease progression or death from any cause, whichever occurs first.
7 secondary outcomes
Investigator-Assessed Real-World Objective Response Rate (rwORR)
Time frame: From the first dose of sevabertinib through the last available tumor response assessment, up to 12 months.
Investigator-Assessed Real-World Disease Control Rate (rwDCR)
Time frame: From the first dose of sevabertinib through the last available tumor response assessment, up to 12 months.
6-Month and 12-Month Progression-Free Survival Rates
Time frame: At 6 months and 12 months after the first dose of sevabertinib.
Incidence of Treatment-Related Adverse Events
Time frame: From the first dose of sevabertinib through the last available safety assessment, up to 12 months.
Change From Baseline in EORTC QLQ-C30 Scores
Time frame: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
Change From Baseline in NSCLC-SAQ Total Score
Time frame: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
Change From Baseline in EQ-5D-5L Index Score
Time frame: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
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 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be shared with external researchers because the study uses sensitive clinical data derived from medical records and follow-up. Study data are de-identified and managed under applicable confidentiality, privacy, and institutional data security requirements, with access restricted to authorized study personnel.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-mutant Advanced Non-Small Cell Lung Cancer, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yi XIANG (+86-13816967846, xiangyiht@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-World Progression-Free Survival (rwPFS) (time frame: From the first dose of sevabertinib until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.). 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 5 Nov 2026.