Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study (RERUN)

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Peking University International Hospital
NOT_YET_RECRUITING
Beijing
Hunan Second People's Hospital
NOT_YET_RECRUITING
Changsha
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
NOT_YET_RECRUITING
Hefei
Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
First Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Jinzhou Medical University
NOT_YET_RECRUITING
Jinzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
NOT_YET_RECRUITING
Shanghai
Zhongshan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
NOT_YET_RECRUITING
Shenzhen
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shangxi Provincial Cancer Hospital
RECRUITING
Taiyuan
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Contact for Clinical Trial Information
CTRinfo_us@daiichisankyo.com
908-992-6400
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2027-02-12
Participants
Target number of participants: 150
Treatments
NSCLC patients with HER2 mutations
Patients with NSCLC with HER2 mutations who receive T-DXd based on physician's decisions will be enrolled.
Sponsors
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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