Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
← catalyst calendarNCT06350097 · readout in 580 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
582estimated
Sites
166
Countries
Australia, Brazil, Canada +16
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 | 2024-04-29 | actual | When the study began enrolling |
| Primary completion | 2028-03-21 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-08-29 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | 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: Osimertinib — also filed as Osimertinib: Tagrisso, AZD9291
- Drug: Datopotamab Deruxtecan — also filed as Dato-DXd, DS-1062a
Primary outcome
what the primary-completion date above is the date OFTo demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants.
measured It is anticipated that it will be performed approximately 3 years after the first participant is randomised.
Publications
- PMID 42182601 — 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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