Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study (RERUN)
Daiichi Sankyo
150 participants
Feb 21, 2025
OBSERVATIONAL
Conditions
Summary
Trastuzumab deruxtecan (T-DXd) is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations. This real world, prospective study will assess the effectiveness and safety of T-DXd in patients with locally advanced or metastatic, HER2 mutation-positive NSCLC in real-world setting.
Eligibility
Inclusion Criteria5
- Age ≥18 years at signing informed consent form (ICF).
- Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
- Documented any known activating HER2 mutation.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Patients who receive T-DXd based on physicians' discretion (Newly received or just have started the first dose no longer than 2 months before enrollment).
Exclusion Criteria5
- Previously treated with HER2-targeted/directed therapies, including:
- tyrosine kinase inhibitors \[TKIs\] targeting HER2 mutations, except for pan-HER class TKIs.
- an ADC, containing a chemotherapeutic agent targeting topoisomerase I
- Has spinal cord compression or clinically active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.
Interventions
This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd will be enrolled in this study.
Locations(23)
View Full Details on ClinicalTrials.gov
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NCT06809764