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

Официальное название

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

Обзор

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.

Подробное описание

T-DXd is an approved therapy in China for locally advanced or metastatic NSCLC patients with human epidermal growth factor receptor 2 mutations (HER2m). In previous clinical trials, T-DXd demonstrated efficacy and manageable safety profiles in the ≥ second-line setting for NSCLC harboring HER2m. However, patient populations are more diverse in routine practice and no real-world data of T-DXd used in Chinese lung cancer patients with HER2 mutations exist.

This study will assess the effectiveness of ≥ second-line treatment of T-DXd in real-world setting as the primary objective. Secondary objectives will further assess the effectiveness and overall survival of ≥ second-line treatment of T-DXd in real-world setting as well as evaluate the safety and tolerability of any-line treatment of T-DXd in real-world setting. 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.

Вмешательства

• Другое No 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.

Первичные конечные точки

• Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS) [Срок оценки: Baseline up to approximatley 2 years]

Вторичные конечные точки (4)

• Time to Treatment Discontinuation or Death (TTD) [Срок оценки: Baseline up to approximately 2 years]
• Best Overall Response Rate (BORR) [Срок оценки: Baseline up to approximately 2 years]
• Overall Survival [Срок оценки: Baseline up to approximately 2 years]
• Number of Patients Reporting Treatment-related Adverse Events (TRAEs), Adverse Events of Special Interests (AESIs), and AEs Leading to Dose Interruption, Reduction, Discontinuation [Срок оценки: Baseline up to approximately 2 years]

Критерии участия

The key 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 23 центра

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Peking University International Hospital — Пекин
• Beijing Cancer Hospital — Пекин
• Hunan Second People's Hospital — Чанша
• Fujian Cancer Hospital — Фучжоу
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу
• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Zhejiang Cancer Hospital — Ханчжоу
• … и ещё 15 центров

Идентификаторы

NCT: NCT06809764 · DS8201-0079-NIS-MA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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