A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
454actual
Sites
130
Countries
Austria, Belgium, Brazil +17
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 | 2021-10-28 | actual | When the study began enrolling |
| Primary completion | 2026-06-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-09-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Interventions
- Drug: Trastuzumab Deruxtecan — also filed as DS-8201a; T-DXd
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pembrolizumab
- Drug: Pemetrexed
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS) by Blinded Independent Central Review (BICR)
measured Until progression or death, assessed up to approximately 12 months
Permalink · AZN's whole pipeline · Catalyst calendar · Every registered study · What changed