Clinical trial NCT06809764: Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
Official title: Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study (RERUN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Locally advanced or metastatic NSCLC
HER2 mutations
T-DXd
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC patients with HER2 mutations who receive T-DXd based on physicians' discretion will be enrolled from about 30 sites in China.

Brief 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.

Detailed description: 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.

Eligibility criteria: The key inclusion criteria for this study are:

1. Age ≥18 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.

Primary outcomes:
measure: Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)
timeFrame: Baseline up to approximatley 2 years
Secondary outcomes:
measure: Time to Treatment Discontinuation or Death (TTD)
timeFrame: Baseline up to approximately 2 years
measure: Best Overall Response Rate (BORR)
timeFrame: Baseline up to approximately 2 years
measure: Overall Survival
timeFrame: Baseline up to approximately 2 years
measure: Number of Patients Reporting Treatment-related Adverse Events (TRAEs), Adverse Events of Special Interests (AESIs), and AEs Leading to Dose Interruption, Reduction, Discontinuation
timeFrame: Baseline up to approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University International Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changsha
country: China
facility: Hunan Second People's Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Jinan
country: China
facility: First Affiliated Hospital of Shandong First Medical University
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shangxi Provincial Cancer Hospital
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Daiichi Sankyo (China) Holdings Co., Ltd.
name: Project Manager
role: STUDY_DIRECTOR
References: