A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
← catalyst calendarNCT06564844 · readout in 315 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
25actual
Sites
90
Countries
Brazil, Canada, Hong Kong +7
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 | 2024-10-15 | actual | When the study began enrolling |
| Primary completion | 2027-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-21 | actual | When this record first appeared on the registry |
| Results posted | — | 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
- Non-small Cell Lung Cancer
Interventions
- Drug: Datopotamab Deruxtecan — also filed as Dato-DXd, DS-1062a
- Drug: Rilvegostomig — also filed as AZD2936
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Etoposide
- Drug: Pemetrexed
- Drug: Vinorelbine
- Drug: UFT
Primary outcome
what the primary-completion date above is the date OFDisease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
measured From date of randomisation up to approximately 10 years.
Publications
- PMID 40976544 — 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.
Permalink · AZN's whole pipeline · Catalyst calendar · Every registered study · What changed