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Non-small Cell Lung CancerRERUNNCT06809764

Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)

An observational study of Non-small Cell Lung Cancer, run by Daiichi Sankyo at 36 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
No drug
How many people
150 participants
Where
36 sitesChina
Study dates
21 Feb 2025to 12 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: NSCLC patients with HER2 mutations who receive T-DXd based on physicians' discretion will be enrolled from about 30 sites in China.

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
  1. 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.
  2. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

36 sites in 1 country

China36 sites, 36 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

    Principal Investigator

    Not yet recruiting

  • The History of Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070

    Principal Investigator

    Recruiting

  • Peking University International Hospital

    Beijing, 100125

    Principal Investigator

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Principal Investigator

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Principal Investigator

    Recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149

    Principal Investigator

    Recruiting

  • Hunan Second People's Hospital

    Changsha, 410007

    Principal Investigator

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, 350014

    Principal Investigator

    Recruiting

  • Dongguan People's Hospital

    Guangdong, 523000

    Principal Investigator

    Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, 510060

    Principal Investigator

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510062

    Principal Investigator

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Principal Investigator

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences （Langfang Section)

    Hebei, 065000

    Principal Investigator

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, 230031

    Principal Investigator

    Recruiting

  • Hubei Cancer Hospital

    Hubei, 430079

    Principal Investigator

    Recruiting

  • Nanjing Drum Tower Hospital

    Jiangsu, 210008

    Principal Investigator

    Recruiting

  • Affiliated Hospital of Nantong University

    Jiangsu, 226001

    Principal Investigator

    Recruiting

  • Jiangxi Cancer Hospital

    Jiangxi, 330029

    Principal Investigator

    Recruiting

  • First Affiliated Hospital of Shandong First Medical University

    Jinan, 250014

    Principal Investigator

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, 250103

    Principal Investigator

    Not yet recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, 121001

    Principal Investigator

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330000

    Principal Investigator

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, 541000

    Principal Investigator

    Not yet recruiting

  • The Affiliated Hospital of Qingdao University

    Shandong, 266000

    Principal Investigator

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, 200025

    Principal Investigator

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

    Principal Investigator

    Not yet recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Principal Investigator

    Recruiting

  • Shanghai Geriatric Medical Hospital

    Shanghai, 201100

    Principal Investigator

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, 110001

    Principal Investigator

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, 518116

    Principal Investigator

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, 050011

    Principal Investigator

    Recruiting

  • Shangxi Provincial Cancer Hospital

    Taiyuan, 030013

    Principal Investigator

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361102

    Principal Investigator

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Zhejiang, 310009

    Principal Investigator

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450052

    Principal Investigator

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

    Principal Investigator

    Not yet recruiting

Other trials in China

About this study

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)

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.

Read the detailed description

T-DXd is an approved therapy in China for locally advanced or metastatic NSCLC patients with human epidermal growth factor receptor 2 mutations (HER2m). In previous clinical trials, T-DXd demonstrated efficacy and manageable safety profiles in the ≥ second-line setting for NSCLC harboring HER2m. However, patient populations are more diverse in routine practice and no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations exist.

This study will assess the effectiveness of ≥ second-line treatment of T-DXd in real-world setting as the primary objective. Secondary objectives will further assess the effectiveness and overall survival of ≥ second-line treatment of T-DXd in real-world setting as well as evaluate the safety and tolerability of any-line treatment of T-DXd in real-world setting. 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.

Being tested
No drug
Keywords
Locally advanced or metastatic NSCLC, HER2 mutations, T-DXd
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No drugOther

    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.

Study groups in NCT06809764
Study groupRoleWhat they receive
NSCLC patients with HER2 mutationsPatients with NSCLC with HER2 mutations who receive T-DXd based on physician's decisions will be enrolled.
Receives: Other: No drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)

    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).

    Measured: Baseline up to approximatley 2 years

Secondary outcomes (4)

  1. Time to Treatment Discontinuation or Death (TTD)

    TTD is defined as the time from the initiated date of ≥ second-line treatment of T-DXd to the date of treatment discontinuation or death from any cause.

    Measured: Baseline up to approximately 2 years

  2. Best Overall Response Rate (BORR)

    BORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as assessed by investigator for ≥ second-line treatment of T-DXd. Based on RECIST guidelines, CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Baseline up to approximately 2 years

  3. Overall Survival

    Overall survival is defined as the time from the initiated date of ≥ second-line treatment of T-DXd until death due to any cause.

    Measured: Baseline up to approximately 2 years

  4. Number of Patients Reporting Treatment-related Adverse Events (TRAEs), Adverse Events of Special Interests (AESIs), and AEs Leading to Dose Interruption, Reduction, Discontinuation

    TRAEs, AESIs and AEs leading to dose interruption, reduction, discontinuation will be graded by the investigators using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 and coded using the medical dictionary for regulatory activities (MedDRA).

    Measured: Baseline up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start21 Feb 2025
  3. Primary completion12 Feb 2027 (estimated)
  4. Study completion12 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809764
Sponsor's protocol ID
DS8201-0079-NIS-MA
Acronym
RERUN
Status last verified
Aug 2026
First submitted
30 Jan 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Duan 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.

    PubMed 42667570

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer, run by Daiichi Sankyo at 36 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS) (time frame: Baseline up to approximatley 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06809764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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