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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (36)

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