Real-world results of sevabertinib in advanced HER2-mutant non-small cell lung cancer
Observes how sevabertinib works and how safe it is in lung cancer.
Plain-language title generated from the registry record
Registry title: Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
Key facts
- Where
- Qionghai, ChinaSee the site
Where in China
- Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)Qionghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07880353
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Receipt of another unapproved investigational drug or non-drug treatment within 30 days before the index date or during the observation period; 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.