Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
RERUN
1 other identifier
observational
150
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 12, 2027
May 28, 2025
May 1, 2025
2 years
January 30, 2025
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
Baseline up to approximatley 2 years
Secondary Outcomes (4)
Time to Treatment Discontinuation or Death (TTD)
Baseline up to approximately 2 years
Best Overall Response Rate (BORR)
Baseline up to approximately 2 years
Overall Survival
Baseline up to approximately 2 years
Number of Patients Reporting Treatment-related Adverse Events (TRAEs), Adverse Events of Special Interests (AESIs), and AEs Leading to Dose Interruption, Reduction, Discontinuation
Baseline up to approximately 2 years
Study Arms (1)
NSCLC patients with HER2 mutations
Patients with NSCLC with HER2 mutations who receive T-DXd based on physician's decisions will be enrolled.
Interventions
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.
Eligibility Criteria
NSCLC patients with HER2 mutations who receive T-DXd based on physicians' discretion will be enrolled from about 30 sites in China.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (23)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking University International Hospital
Beijing, 100125, China
Beijing Cancer Hospital
Beijing, 100142, China
Hunan Second People's Hospital
Changsha, 410007, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, 510060, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510062, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Anhui Provincial Cancer Hospital
Hefei, 230031, China
First Affiliated Hospital of Shandong First Medical University
Jinan, 250014, China
Cancer Hospital of Shandong First Medical University
Jinan, 250103, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, 121001, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330000, China
Guangxi Medical University Cancer Hospital
Nanning, 541000, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, 200025, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
The First Hospital of China Medical University
Shenyang, 110001, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, 518116, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, 050011, China
Shangxi Provincial Cancer Hospital
Taiyuan, 030013, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361102, China
Henan Cancer Hospital
Zhengzhou, 450052, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Manager
Daiichi Sankyo Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2025
First Posted
February 5, 2025
Study Start
February 21, 2025
Primary Completion (Estimated)
February 12, 2027
Study Completion (Estimated)
February 12, 2027
Last Updated
May 28, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share