NCT06809764

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-02-21
• Primary completion: 2027-02-12
• Completion: 2027-02-12
• First posted: 2025-02-05
• Last updated: 2025-05-28

Locations

23 sites across 1 country: China