An observational study in HER2-mutant Advanced Non-Small Cell Lung Cancer, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Ruijin Hospital · Observational
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.
Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Sevabertinib
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.
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.
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.
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.
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)
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.
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
The probabilities of participants being alive and free from disease progression at 6 months and 12 months after the first dose of sevabertinib.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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