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

Recruitingn/aAges 18 Years - anyAllDaiichi Sankyo
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
The key inclusion criteria for this study are: 1. Age โ‰ฅ18 years at signing informed consent form (ICF). 2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC. 3. Documented any known activating HER2 mutation. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 5. 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: 1. 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 2. 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. 3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.
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What it tests

  • No drug
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Where

36 sites
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

โ€ฆand 28 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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