An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
← catalyst calendarSponsored by Incyte Corporation (industry) · INCY — their whole pipeline →. With AstraZeneca.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
59actual
Sites
31
Countries
South Korea, Spain, Taiwan +1
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 | 2016-12-20 | actual | When the study began enrolling |
| Primary completion | 2025-12-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-24 | actual | The whole study's end, after follow-up |
| First posted | 2016-09-28 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lung Cancer
Interventions
- Drug: Itacitinib — also filed as INCB039110
- Drug: Osimertinib
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Frequency, severity, and duration of adverse events (AEs)
measured From screening through 30-35 days after end of treatment, approximately 2 years.
Phase 1: Number of subjects with dose-limiting toxicities (DLTs)
measured Day 1 through Day 28
Phase 2: Objective response rate (ORR) based on RECIST v1.1
measured Screening and 8-week intervals throughout the study, approximately 2 years.
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