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

Last updated: March 5, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Treatment

No drug

Clinical Study ID

NCT06809764
DS8201-0079-NIS-MA
  • Ages > 18
  • All Genders

Study 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.

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: No drug
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
February 12, 2027

Study 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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021
    China

    Site Not Available

  • Peking University International Hospital

    Beijing, 100125
    China

    Site Not Available

  • Hunan Second People's Hospital

    Changsha, 410007
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, 350014
    China

    Site Not Available

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, 510060
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510062
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Site Not Available

  • Anhui Provincial Cancer Hospital

    Hefei, 230031
    China

    Site Not Available

  • Cancer Hospital of Shandong First Medical University

    Jinan, 250103
    China

    Site Not Available

  • First Affiliated Hospital of Shandong First Medical University

    Jinan, 250014
    China

    Site Not Available

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, 121001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330000
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, 541000
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, 200025
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, 200032
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, 110001
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, 518116
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, 050011
    China

    Site Not Available

  • Shangxi Provincial Cancer Hospital

    Taiyuan, 030013
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361102
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450052
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052
    China

    Site Not Available

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