Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drug | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NSCLC patients with HER2 mutations
- description
- Patients with NSCLC with HER2 mutations who receive T-DXd based on physician's decisions will be enrolled.
- interventionNames
- Other: No drug
Primary outcomes (1)
- measure
- Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)
- timeFrame
- Baseline up to approximatley 2 years
- description
- rwPFS is defined as the time from the initiated date of ≥ second-line treatment of T-DXd until disease progression or death by investigator report as recorded in the electronic case report forms (eCRF).
Secondary outcomes (4)
- measure
- Time to Treatment Discontinuation or Death (TTD)
- timeFrame
- Baseline up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The key inclusion criteria for this study are: 1. Age ≥18 years at signing informed consent form (ICF). 2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC. 3. Documented any known activating HER2 mutation. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 5. 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). The key exclusion criteria for this study are: 1. 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 2. 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. 3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.
References
Publications (1)
- DERIVEDDuan J, Zhuo M, Su C, Liu Y, Wang L, Yang N, Cao B, Hu M, Jin S, Li H, Li X, Pan Y, Hu J, Lu D, Tang C, Yang B, Huang Y, Jiang G, Li W, Ni S, Sheng W, Tang K, Wang J, Wang Q, Wang Z, Si S, Wang J. Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients with HER2-Mutant Metastatic Non-Small Cell Lung Cancer (RERUN): Study Protocol for a Real-World, Multicenter, Prospective, Observational Study. Adv Ther. 2026 Aug 29. doi: 10.1007/s12325-026-03729-7. Online ahead of print. PMID 42667570