HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
← catalyst calendarSponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Daiichi Sankyo Co., Ltd., Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
277actual
Sites
123
Countries
Australia, Austria, Belgium +13
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 | 2021-02-02 | actual | When the study began enrolling |
| Primary completion | 2022-11-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-04 | estimated | The whole study's end, after follow-up |
| First posted | 2020-11-06 | actual | When this record first appeared on the registry |
| Results posted | 2024-04-02 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-Small Cell Lung Cancer Metastatic
- Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Interventions
- Drug: Patritumab Deruxtecan (Fixed dose) — also filed as U3-1402, HER3-DXd
- Drug: Patritumab Deruxtecan (Up-Titration) — also filed as U3-1402, HER3-DXd
Primary outcome
what the primary-completion date above is the date OFObjective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
measured Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2021-03-31 · 1.3 MB · Prot_SAP_000.pdf
Publications
- PMID 38958845 — linked by the registry
- PMID 37689979 — linked by the registry
- PMID 37212796 — 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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