Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
Recruiting · NCT06809764 · Observational (researchers observe without assigning treatment) · Lead sponsor: Daiichi Sankyo
View the official record on ClinicalTrials.gov →Interventions studied
No drug
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- for this study are:
- 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).
- The key
Exclusion criteria
- for this study are:
- 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.
Where it is running
36 locations listed.
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, China
- The History of Beijing Tiantan Hospital, Capital Medical University - Beijing, China
- Peking University International Hospital - Beijing, China
- Beijing Cancer Hospital - Beijing, China
- Peking University Third Hospital - Beijing, China
- Beijing Chest Hospital, Capital Medical University - Beijing, China
- Hunan Second People's Hospital - Changsha, China
- Fujian Cancer Hospital - Fuzhou, China
- Dongguan People's Hospital - Guangdong, 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
- Cancer Hospital Chinese Academy of Medical Sciences （Langfang Section) - Hebei, China
- Anhui Provincial Cancer Hospital - Hefei, China
- Hubei Cancer Hospital - Hubei, China
- Nanjing Drum Tower Hospital - Jiangsu, China
- Affiliated Hospital of Nantong University - Jiangsu, China
- Jiangxi Cancer Hospital - Jiangxi, 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
- The Affiliated Hospital of Qingdao University - Shandong, China
- Ruijin Hospital, Shanghai Jiaotong University School Of Medicine - Shanghai, China
- Zhongshan Hospital Fudan University - Shanghai, China
- Shanghai Pulmonary Hospital - Shanghai, China
- Shanghai Geriatric Medical Hospital - 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
- The Second Affiliated Hospital Zhejiang University School of Medicine - Zhejiang, China
- Henan Cancer Hospital - Zhengzhou, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, China