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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

tyrosine kinase inhibitors [TKIs] targeting HER2 mutations, except for pan-HER class TKIs.

an ADC, containing a chemotherapeutic agent targeting topoisomerase I

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.

Trial design

Treatments tested in this trial

  • No drug

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators