Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
← catalyst calendarNCT05687266 · readout in 439 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,350actual
Sites
254
Countries
Austria, Brazil, Bulgaria +20
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 | 2022-12-29 | actual | When the study began enrolling |
| Primary completion | 2027-11-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-01 | estimated | The whole study's end, after follow-up |
| First posted | 2023-01-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- NSCLC
Interventions
- Drug: Datopotamab deruxtecan — also filed as Dato-DXd, Datroway
- Drug: Durvalumab — also filed as MEDI4736, Imfinzi
- Drug: Carboplatin
- Drug: Pembrolizumab
- Drug: Cisplatin
- Drug: Pemetrexed
- Drug: Paclitaxel
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population
measured Approximately 3 years
Overall Survival (OS) in the non-squamous TROP2 biomarker positive population
measured Approximately 5 years
PFS by BICR in the non-squamous population
measured Approximately 3 years
OS in the non-squamous population
measured Approximately 5 years
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