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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

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University International Hospital
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BeijingChinaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
The History of Beijing Tiantan Hospital, Capital Medical University
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BeijingChinaRecruiting
Beijing chest hospital, Capital Medical University
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BeijingChinaRecruiting
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaNot yet recruiting
Peking University Third Hospital
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BeijingChinaRecruiting
Hunan Second People's Hospital
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ChangshaChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
Dongguan People's Hospital
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GuangdongChinaRecruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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GuangzhouChinaRecruiting
the First Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Cancer Hospital Chinese Academy of Medical Sciences (Langfang Section)
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HebeiChinaRecruiting
Anhui Provincial Cancer Hospital
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HefeiChinaRecruiting
Hubei Cancer Hospital
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HubeiChinaRecruiting
Affiliated Hospital of Nantong University
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JiangsuChinaRecruiting
Nanjing Drum Tower Hospital
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JiangsuChinaRecruiting
Jiangxi cancer hospital
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JiangxiChinaRecruiting
First Affiliated Hospital of Shandong First Medical University
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JinanChinaRecruiting
Cancer Hospital of Shandong First Medical University
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JinanChinaNot yet recruiting
The First Affiliated Hospital of Jinzhou Medical University
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JinzhouChinaNot yet recruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaNot yet recruiting
Guangxi Medical University Cancer Hospital
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NanningChinaNot yet recruiting
The Affiliated Hospital of Qingdao University
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ShandongChinaRecruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaRecruiting
Shanghai Geriatric Medical Hospital
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ShanghaiChinaRecruiting
Zhongshan Hospital,Fudan University
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ShanghaiChinaNot yet recruiting
Shanghai Pulmonary Hospital
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ShanghaiChinaRecruiting
The First Hospital of China Medical University
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ShenyangChinaRecruiting
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
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ShenzhenChinaRecruiting
The Fourth Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Shangxi Provincial Cancer Hospital
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TaiyuanChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
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ZhejiangChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.