Sevabertinib in HER2-mutant Advanced NSCLC: Real-world Outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, observational bidirectional cohort study conducted in Chinese adults with HER2-mutant advanced NSCLC who are receiving Sevabertinib as second-line or later therapy. The study collects both retrospective and prospective patient data to evaluate real-world progression-free survival, tumor response, overall survival, safety, and patient-reported quality of life. Treatment decisions are made by physicians in routine practice, not by protocol-mandated interventions. Primary outcome focuses on real-world progression-free survival, with secondary endpoints including safety and QoL. Eligible participants include adults with unresectable or metastatic non-squamous NSCLC harboring activating HER2 TKD mutations who have had prior systemic therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years at the index date.
2. Unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
3. Documented HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutation.
4. 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.
5. For retrospectively included participants, sufficient baseline clinical, treatment, and prior follow-up data are available.
6. Sevabertinib treatment has been determined by the treating physician based on clinical practice, or the participant has already initiated sevabertinib at screening.

Exclusion Criteria:

1. History of Grade 3 or higher interstitial lung disease (ILD), or evidence of any clinically active ILD.
2. 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.
3. Unstable brain metastases.
4. Inability to comply with the study for any reason.
5. Receipt of another unapproved investigational drug or non-drug treatment within 30 days before the index date or during the observation period.

Where it's running

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

Study contacts

• Study coordinator: Yi XIANG
• Email: xiangyiht@163.com
• Phone: +86-13816967846

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment for solid tumors with HER2 mutations using BAY2927088 tablets

  This study is testing if BAY2927088 tablets can help people with advanced solid tumors that have HER2 gene mutations feel better and manage their cancer.

  Recruiting at 33 sites Phase 2 Bayer · Birmingham, Alabama and 53 other locations · NCT06760819

• Evaluating BAY 2927088 for Advanced Lung Cancer with HER2 Mutations

  This study is testing a new drug called BAY 2927088 to see if it can help people with advanced lung cancer that has specific HER2 mutations feel better compared to standard treatments.

  Recruiting at 37 sites Phase 3 Bayer · Newport Beach, California and 278 other locations · NCT06452277

• AI-assisted 4D PET imaging to detect early pancreatic cancer lesions

  This study tests whether AI-assisted 4D long-axial PET imaging with FDG and FAPI can help detect early PDAC lesions in patients with suspected pancreatic tumors.

  Recruiting Ruijin Hospital · Shanghai · NCT07925125

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

  This trial tests whether modular robotic-assisted esophagectomy using the Carina platform works better than conventional 3D thoracoscopic esophagectomy for people with resectable esophageal cancer.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT07888140

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.