RecruitingNot Applicable

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

China150 participantsStarted 2025-02-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. Previously treated with HER2-targeted/directed therapies, including:
✕. 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.

What they're measuring

Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)

Timeframe: Baseline up to approximatley 2 years

Trial details

NCT IDNCT06809764

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02-12

Contact for this trial

Contact for Clinical Trial Information

908-992-6400 CTRinfo_us@daiichisankyo.com

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials