NCT06809764 Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
| NCT ID | NCT06809764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daiichi Sankyo |
| Condition | Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2027-02-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-02-21 with a primary completion date of 2027-02-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
The key inclusion criteria for this study are: 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). The key exclusion criteria for this study are: 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.
Contact & Investigator
Project Manager
STUDY DIRECTOR
Daiichi Sankyo Co., Ltd.
Frequently Asked Questions
Who can join the NCT06809764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06809764 currently recruiting?
Yes, NCT06809764 is actively recruiting participants. Contact the research team at CTRinfo_us@daiichisankyo.com for enrollment information.
Where is the NCT06809764 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Changsha, China and 11 additional locations.
Who is sponsoring the NCT06809764 clinical trial?
NCT06809764 is sponsored by Daiichi Sankyo. The principal investigator is Project Manager at Daiichi Sankyo Co., Ltd.. The trial plans to enroll 150 participants.
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