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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 (36) 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
RECRUITING
Beijing
Beijing Chest Hospital, Capital Medical University
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Peking University International Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The History of Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Hunan Second People's Hospital
RECRUITING
Changsha
Fujian Cancer Hospital
RECRUITING
Fuzhou
Dongguan People's Hospital
RECRUITING
Guangdong
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Cancer Hospital Chinese Academy of Medical Sciences （Langfang Section)
RECRUITING
Hebei
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Hubei Cancer Hospital
RECRUITING
Hubei
Affiliated Hospital of Nantong University
RECRUITING
Jiangsu
Nanjing Drum Tower Hospital
RECRUITING
Jiangsu
Jiangxi Cancer Hospital
RECRUITING
Jiangxi
Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
First Affiliated Hospital of Shandong First Medical University
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
The Affiliated Hospital of Qingdao University
RECRUITING
Shandong
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
RECRUITING
Shanghai
Shanghai Geriatric Medical Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Zhongshan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
The First Hospital of China Medical University
RECRUITING
Shenyang
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
RECRUITING
Shenzhen
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shangxi Provincial Cancer Hospital
RECRUITING
Taiyuan
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Zhejiang
Henan Cancer Hospital
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.
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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