NCT06809764Recruiting
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 · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 21 Feb 2025
- Primary completion date
- 12 Feb 2027
- Lead sponsor
- Daiichi Sankyo
- Diseases
- Lung cancer
- NCT number
- NCT06809764
What you commit to
- Study type: Observational
- Planned participants: 150
- From 21 Feb 2025 to the primary completion date, 12 Feb 2027
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- The key inclusion criteria for this study are:
- 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).
- The key exclusion criteria for this study are:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University International Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The History of Beijing Tiantan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing chest hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Second People's Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Guangdong | China | Recruiting |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| the First Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences (Langfang Section) Coordinator of this site? Confirm its status | Hebei | China | Recruiting |
| Anhui Provincial Cancer Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Hubei | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Jiangsu | China | Recruiting |
| Nanjing Drum Tower Hospital Coordinator of this site? Confirm its status | Jiangsu | China | Recruiting |
| Jiangxi cancer hospital Coordinator of this site? Confirm its status | Jiangxi | China | Recruiting |
| First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Cancer Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| The First Affiliated Hospital of Jinzhou Medical University Coordinator of this site? Confirm its status | Jinzhou | China | Not yet recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Shandong | China | Recruiting |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Geriatric Medical Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Shangxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.