Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
← catalyst calendarSponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
605actual
Sites
209
Countries
Argentina, Australia, Belgium +23
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 | 2020-12-21 | actual | When the study began enrolling |
| Primary completion | 2024-05-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-15 | estimated | The whole study's end, after follow-up |
| First posted | 2020-12-07 | actual | When this record first appeared on the registry |
| Results posted | 2025-07-23 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-31 | 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: DS-1062a — also filed as Datopotamab deruxtecan (Dato-DXd)
- Drug: Docetaxel
Primary outcomes
what the primary-completion date above is the date OFProgression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
measured From randomization until disease progression or death (whichever occurs first), up to approximately 27 months
Overall Survival (OS) Following DS-1062a Versus Docetaxel
measured From randomization until date of death due to any cause, up to to approximately 38 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2023-10-09 · 5.8 MB · Prot_SAP_000.pdf
Publications
- PMID 41268710 — linked by the registry
- PMID 40516821 — linked by the registry
- PMID 39250535 — 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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