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

Recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT06809764
• Lead Sponsor: Daiichi Sankyo

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.

Study Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-05
• Study Start: 2025-02-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Primary Completion: 2027-02-12
• Study Completion: 2027-02-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)	Baseline up to approximatley 2 years	rwPFS is defined as the time from the initiated date of ≥ second-line treatment of T-DXd until disease progression or death by investigator report as recorded in the electronic case report forms (eCRF).

Secondary Outcome Measures

Name	Time	Method
Time to Treatment Discontinuation or Death (TTD)	Baseline up to approximately 2 years	TTD is defined as the time from the initiated date of ≥ second-line treatment of T-DXd to the date of treatment discontinuation or death from any cause.
Best Overall Response Rate (BORR)	Baseline up to approximately 2 years	BORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as assessed by investigator for ≥ second-line treatment of T-DXd. Based on RECIST guidelines, CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Overall Survival	Baseline up to approximately 2 years	Overall survival is defined as the time from the initiated date of ≥ second-line treatment of T-DXd until death due to any cause.
Number of Patients Reporting Treatment-related Adverse Events (TRAEs), Adverse Events of Special Interests (AESIs), and AEs Leading to Dose Interruption, Reduction, Discontinuation	Baseline up to approximately 2 years	TRAEs, AESIs and AEs leading to dose interruption, reduction, discontinuation will be graded by the investigators using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 and coded using the medical dictionary for regulatory activities (MedDRA).

Trial Locations

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