NCT07880353Not yet recruiting
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 16 (estimated)
- First submitted
- 27 Sept 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07880353
What you commit to
- Study type: Observational
- Planned participants: 16
- From 30 Sept 2026 to the primary completion date, 30 Sept 2028
- 1 site in 1 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
- Receipt of another unapproved investigational drug or non-drug treatment within 30 days before the index date or during the observation period.
Other illness
- 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.
Other
- Unstable brain metastases.
- Inability to comply with the study for any reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital) Coordinator of this site? Confirm its status | Qionghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.