RecruitingNCT06809764

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

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

Sponsor

Daiichi Sankyo

Enrollment

150 participants

Start Date

Feb 21, 2025

Study Type

OBSERVATIONAL

Conditions

Non-small Cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the real-world safety and effectiveness of trastuzumab deruxtecan (T-DXd), a targeted cancer drug, in patients with HER2-positive or HER2-low cancer. T-DXd is an antibody-drug conjugate — it attaches to cancer cells and delivers chemotherapy directly inside them. **You may be eligible if...** - You have been diagnosed with HER2-positive or HER2-low cancer (such as breast or gastric cancer) - You are currently receiving or being considered for trastuzumab deruxtecan treatment - You meet the study's age and performance requirements **You may NOT be eligible if...** - You have severe lung disease or active interstitial lung disease - Your organ function (heart, liver, kidneys) is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo drug

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.

Locations(23)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Peking University International Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

Hunan Second People's Hospital

Changsha, China

Fujian Cancer Hospital

Fuzhou, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Anhui Provincial Cancer Hospital

Hefei, China

First Affiliated Hospital of Shandong First Medical University

Jinan, China

Cancer Hospital of Shandong First Medical University

Jinan, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Guangxi Medical University Cancer Hospital

Nanning, China

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, China

Zhongshan Hospital Fudan University

Shanghai, China

The First Hospital of China Medical University

Shenyang, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Shangxi Provincial Cancer Hospital

Taiyuan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Henan Cancer Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06809764

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