Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
← catalyst calendarNCT06357533 · readout in 1,227 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
675estimated
Sites
287
Countries
Australia, Austria, Belgium +18
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 | 2024-04-11 | actual | When the study began enrolling |
| Primary completion | 2029-12-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-12-28 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Small Cell Lung Cancer
Interventions
- Drug: Datopotamab Deruxtecan — also filed as Dato-DXd
- Drug: Rilvegostomig — also filed as AZD2936
- Drug: Pembrolizumab — also filed as KEYTRUDA
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival (PFS) in TROP2 biomarker positive participants.
measured Approximately 4 years
Overall Survival (OS) in TROP2 biomarker positive participants.
measured Approximately 6 years
Publications
- PMID 41669261 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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