A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
72actual
Sites
28
Country
China
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-07-13 | actual | When the study began enrolling |
| Primary completion | 2024-11-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-02-18 | actual | When this record first appeared on the registry |
| Results posted | 2024-12-04 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HER2-mutant Non-Small Cell Lung Cancer
Intervention
- Drug: Trastuzumab deruxtecan — also filed as T-DXd, DS-8201a
Primary outcome
what the primary-completion date above is the date OFICR-assessed ORR (Objective Response Rate)
measured Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-02-24 · 11.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-09-22 · 3.2 MB · SAP_001.pdf
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