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Can Real-World data confirm T-DXd's promise in HER2-Mutant lung cancer?

NCT ID NCT06809764

Knowledge-focused Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This observational study is looking at how well the drug trastuzumab deruxtecan (T-DXd) works and how safe it is in Chinese patients with advanced non-small cell lung cancer that has a specific HER2 mutation. Researchers will follow about 150 patients who are already receiving T-DXd as part of their normal care, tracking how long they live without the cancer growing and any side effects they experience. The goal is to see if the benefits seen in clinical trials hold up in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate, observed in routine clinical practice
What this could lead to
If successful, this study could provide real-world evidence on how well T-DXd works and its safety in Chinese patients with HER2-mutant lung cancer, potentially guiding treatment decisions.
What could go wrong
As an observational study, it cannot prove cause and effect, and results may be influenced by patient selection and real-world variability. Safety and effectiveness may differ from clinical trial findings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    36 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    RECRUITING

    Guangzhou, 510060, China

  • Affiliated Hospital of Nantong University

    RECRUITING

    Jiangsu, 226001, China

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, 230031, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • Beijing Chest Hospital, Capital Medical University

    RECRUITING

    Beijing, 101149, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Beijing, 100021, China

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

    RECRUITING

    Hebei, 065000, China

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    RECRUITING

    Shenzhen, 518116, China

  • Cancer Hospital of Shandong First Medical University

    NOT_YET_RECRUITING

    Jinan, 250103, China

  • Dongguan People's Hospital

    RECRUITING

    Guangdong, 523000, China

  • First Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Jinan, 250014, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, 350014, China

  • Guangxi Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Nanning, 541000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, 450052, China

  • Hubei Cancer Hospital

    RECRUITING

    Hubei, 430079, China

  • Hunan Second People's Hospital

    RECRUITING

    Changsha, 410007, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Jiangxi, 330029, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Jiangsu, 210008, China

  • Peking University International Hospital

    RECRUITING

    Beijing, 100125, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    RECRUITING

    Shanghai, 200025, China

  • Shanghai Geriatric Medical Hospital

    RECRUITING

    Shanghai, 201100, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, 200433, China

  • Shangxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, 030013, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Shandong, 266000, China

  • The First Affiliated Hospital of Jinzhou Medical University

    NOT_YET_RECRUITING

    Jinzhou, 121001, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, 330000, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, 510062, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, 361102, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, 450052, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, 110001, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050011, China

  • The History of Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, 100070, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Zhejiang, 310009, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, 310022, China

  • Zhongshan Hospital Fudan University

    NOT_YET_RECRUITING

    Shanghai, 200032, China

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