Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer
← catalyst calendarNCT05693090 · readout in 341 d
Sponsored by Kura Oncology, Inc. (industry) · KURA — their whole pipeline →.
Phase
Phase 1
Status
Withdrawn
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
0actual
Sites
2
Country
United States
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
Why the sponsor stopped it
This study was withdrawn due to a strategic business decision; no patients were enrolled.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-02-01 | estimated | When the study began enrolling |
| Primary completion | 2027-07-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-27 | estimated | The whole study's end, after follow-up |
| First posted | 2023-01-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-03-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- NSCLC
Interventions
- Drug: Tipifarnib
- Drug: Osimertinib
Primary outcomes
what the primary-completion date above is the date OFFor Dose Escalation determine a safe and tolerable Phase 2 dose of tipifarnib when used in combination with osimertinib
measured At the end of Cycle 1 (each cycle is 28 days)
For Dose Escalation characterize the safety of the combination DLTs will be listed for patients who complete the evaluation period for DLT
measured DLTs will be evaluated at the end of cycle 1 (28 days), but also through study completion, an average of 1.5 years
For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using descriptive statistics of adverse events
measured Through study completion, an average of 2 years
For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using the percentage of patients who discontinue the combination for related adverse events
measured First 6 cycles of treatment (28 day treatment cycle)
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