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)

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) - REAL-HER2 Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059178

Enrollment

Registered

2025-09-25

Start date

2026-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients aged >_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.

Exclusion criteria

Exclusion criteria: 1.Patients who declined to participate in the study. 2.Patients deemed inappropriate for inclusion based on the investigator's judgment.

Design outcomes

Primary

Measure	Time frame
rwPFS (real-world Progression Free Survival)	—

Secondary

Measure	Time frame
1) OS (Overall Survival) 2) TTF (Time to treatment failure) 3) rwORR (Real-world objective response rate) 4) rwDCR (Real-world disease control rate) 5) Treatment duration 6) Adverse Event 7) Analysis of prognostic factors	—

Countries

Japan

Contacts

Public ContactNaoki Ishizuka

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results