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NOT YET RECRUITING
NCT07880353

Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

16

Start Date

2026-09-30

Completion Date

2028-09-30

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

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.

Locations (1)

Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)

Qionghai, Hainan, China