Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
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Phase
—
Status
Completed
Study type
Observational
Enrollment
40actual
Sites
1
Country
Japan
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 | 2020-01-24 | actual | When the study began enrolling |
| Primary completion | 2025-04-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-25 | actual | The whole study's end, after follow-up |
| First posted | 2019-11-07 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-11 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- EGFR Mutation-positive Inoperable or Reccrent NSCLC
Intervention
- Drug: dacomitinib hydrate — also filed as VIZIMPRO
Primary outcome
what the primary-completion date above is the date OFThe Number and Percentage of Participants With Interstitial Lung Disease (ILD)
measured 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-07-18 · 2.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-04-24 · 214 KB · SAP_001.pdf
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