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Observes trastuzumab deruxtecan use in Chinese people with HER2-mutant lung cancer

Follows adults with HER2-mutant advanced non-small cell lung cancer receiving trastuzumab deruxtecan in routine care.

Key facts

Who runs it
Daiichi Sankyo
Where
Beijing, Changsha, Fuzhou, Guangdong, Guangzhou, Hangzhou, Hebei, Hefei, Hubei, Jiangsu, Jiangxi, Jinan, Jinzhou, Nanchang, Nanning, Shandong, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Taiyuan, Xiamen, Zhejiang, and Zhengzhou, ChinaSee the 36 sites
Trial code
Registry title
Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
Status
Recruiting
People taking part
150 people, planned
Started
21 Feb 2025
Expected to end
12 Feb 2027
Type of study
Observational
Treatments tested
  • No drug
Record updated
18 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic non-squamous non-small cell lung cancer who have a HER2 mutation and are starting trastuzumab deruxtecan (T-DXd).

Age
18 years or older
Sex
All sexes can join.
Disease stage
Non-squamous non-small cell lung cancer that cannot be removed by surgery and/or has spread (metastatic). ECOG performance status 0-2.
Earlier treatment
Must have started T-DXd based on the doctor's decision, newly or no longer than 2 months before enrolment. Must not have had earlier HER2-targeted therapy (except pan-HER class TKIs) or an ADC with a topoisomerase I agent.
Biomarker or test result
Any known activating HER2 mutation.

Main reasons for not taking part

  • Earlier HER2-targeted therapy, such as TKIs targeting HER2 mutations (pan-HER class TKIs are allowed)
  • Earlier ADC containing a topoisomerase I chemotherapy agent
  • Spinal cord compression
  • Active brain or CNS metastases that are untreated and cause symptoms, or need corticosteroids or anticonvulsants
  • Severe or uncontrolled illness, such as uncontrolled high blood pressure or active bleeding disorders

The registry criteria, word for word

Show all 9 criteriaShow less

Other criteria

  • 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

Where in China

  • Beijing Cancer HospitalBeijing, ChinaContact: Principal InvestigatorTaking people
  • Beijing chest hospital, Capital Medical UniversityBeijing, ChinaContact: Principal InvestigatorTaking people
  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Principal InvestigatorNot yet recruiting
  • Peking University International HospitalBeijing, ChinaContact: Principal InvestigatorTaking people
  • Peking University Third HospitalBeijing, ChinaContact: Principal InvestigatorTaking people
  • The History of Beijing Tiantan Hospital, Capital Medical UniversityBeijing, ChinaContact: Principal InvestigatorTaking people
  • Hunan Second People's HospitalChangsha, ChinaContact: Principal InvestigatorTaking people
  • Fujian Cancer HospitalFuzhou, ChinaContact: Principal InvestigatorTaking people
  • Dongguan People's HospitalGuangdong, ChinaContact: Principal InvestigatorTaking people
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical UniversityGuangzhou, ChinaContact: Principal InvestigatorTaking people
  • the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaContact: Principal InvestigatorTaking people
  • Zhejiang Cancer HospitalHangzhou, ChinaContact: Principal InvestigatorTaking people
  • Cancer Hospital Chinese Academy of Medical Sciences （Langfang Section)Hebei, ChinaContact: Principal InvestigatorTaking people
  • Anhui Provincial Cancer HospitalHefei, ChinaContact: Principal InvestigatorTaking people
  • Hubei Cancer HospitalHubei, ChinaContact: Principal InvestigatorTaking people
  • Affiliated Hospital of Nantong UniversityJiangsu, ChinaContact: Principal InvestigatorTaking people
  • Nanjing Drum Tower HospitalJiangsu, ChinaContact: Principal InvestigatorTaking people
  • Jiangxi cancer hospitalJiangxi, ChinaContact: Principal InvestigatorTaking people
  • Cancer Hospital of Shandong First Medical UniversityJinan, ChinaContact: Principal InvestigatorNot yet recruiting
  • First Affiliated Hospital of Shandong First Medical UniversityJinan, ChinaContact: Principal InvestigatorTaking people
  • The First Affiliated Hospital of Jinzhou Medical UniversityJinzhou, ChinaContact: Principal InvestigatorNot yet recruiting
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Principal InvestigatorNot yet recruiting
  • Guangxi Medical University Cancer HospitalNanning, ChinaContact: Principal InvestigatorNot yet recruiting
  • The Affiliated Hospital of Qingdao UniversityShandong, ChinaContact: Principal InvestigatorTaking people
  • Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaContact: Principal InvestigatorTaking people
  • Shanghai Geriatric Medical HospitalShanghai, ChinaContact: Principal InvestigatorTaking people
  • Shanghai Pulmonary HospitalShanghai, ChinaContact: Principal InvestigatorTaking people
  • Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Principal InvestigatorNot yet recruiting
  • The First Hospital of China Medical UniversityShenyang, ChinaContact: Principal InvestigatorTaking people
  • Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen CenterShenzhen, ChinaContact: Principal InvestigatorTaking people
  • The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Principal InvestigatorTaking people
  • Shangxi Provincial Cancer HospitalTaiyuan, ChinaContact: Principal InvestigatorTaking people
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Principal InvestigatorTaking people
  • The Second Affiliated Hospital Zhejiang University School of MedicineZhejiang, ChinaContact: Principal InvestigatorTaking people
  • Henan Cancer HospitalZhengzhou, ChinaContact: Principal InvestigatorTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Principal InvestigatorNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • NSCLC patients with HER2 mutations

    Patients with NSCLC with HER2 mutations who receive T-DXd based on physician's decisions will be enrolled.

    Treatment: No drug

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study (RERUN)
Plain-language title
Observes trastuzumab deruxtecan use in Chinese people with HER2-mutant lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
18 August 2026