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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-21

Study Completion Date

2027-02-12

Brief Summary

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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.

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Detailed Description

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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

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NSCLC patients with HER2 mutations

Patients with NSCLC with HER2 mutations who receive T-DXd based on physician's decisions will be enrolled.

No drug

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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).

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No