Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059178) titled 'A multicenter retrospective observational study of real-world T-DXd treatment for stage4 HER2-mutated non-small cell lung cancer patients in Japan (REAL-HER2 Study) (WJOG21224L)' on Sept. 25.
Study Type:
Observational
Primary Sponsor:
Institute - West Japan Oncology Group
Condition:
Condition - Lung Cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To investigate real-world treatment patterns in previously treated patients with stage IV HER2-mutant non-small cell lung cancer (NSCLC) in Japan, and to assess the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in routine clinical practice.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
_18 years at the time of first administration of T-DXd.
2.Patients diagnosed with stage IV HER2-mutant non-small cell lung cancer (NSCLC) by February 28, 2025.
3.Patients who received their first dose of T-DXd between August 23, 2023, and February 28, 2025.
4.Patients who received T-DXd as second-line or later therapy for stage IV HER2-mutant NSCLC.
Note: Patients with recurrence after definitive therapy (surgery, definitive chemoradiotherapy, or definitive radiotherapy) are excluded.
Key exclusion criteria - 1.Patients who declined to participate in the study.
2.Patients deemed inappropriate for inclusion based on the investigator's judgment.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 19 Day
Date of IRB - 2025 Year 09 Month 09 Day
Anticipated trial start date - 2026 Year 01 Month 31 Day
Last follow-up date - 2027 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066622
Disclaimer: Curated by HT Syndication.
