DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
← catalyst calendarSponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca, Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
115estimated
Sites
30
Countries
France, Spain, United Kingdom +1
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 | 2020-02-10 | actual | When the study began enrolling |
| Primary completion | 2025-07-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-08-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Cancer
- Non-small Cell Lung Carcinoma
Interventions
- Drug: Trastuzumab deruxtecan (DS-8201a)
- Drug: Trastuzumab deruxtecan (DS-8201a)
- Drug: Pembrolizumab — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFDose-limiting toxicities (DLTs), Part 1
measured Within two 3-week cycles (6 weeks)
Objective Response Rate (ORR), Confirmed by Independent Central Review, Part 2
measured Within approximately 30 months
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