NCT06039384 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- up to 470 days
What was measured
Duration of response was defined as the time from the first CR or PR until disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Analysis population: Full Analysis Set. As specified in the Statistical Analysis Plan, analysis of duration of response was to be performed only if the number of responders was ≥5.
Groups in this outcome
INCB099280 50 mg QD Plus Adagrasib 400 mg BID
Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
INCB099280 100 mg BID Plus Adagrasib 400 mg BID
Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
| Group | Source count |
|---|---|
| INCB099280 50 mg QD Plus Adagrasib 400 mg BID | 0 |
| INCB099280 100 mg BID Plus Adagrasib 400 mg BID | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Duration of response was defined as the time from the first CR or PR until disease progression (assessed per RECIST v1.1 by the investigator) or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
- groups
- description
- Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
- id
- OG000
- title
- INCB099280 50 mg QD Plus Adagrasib 400 mg BID
- description
- Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
- id
- OG001
- title
- INCB099280 100 mg BID Plus Adagrasib 400 mg BID
- population Description
- Full Analysis Set. As specified in the Statistical Analysis Plan, analysis of duration of response was to be performed only if the number of responders was ≥5.
- reporting Status
- POSTED
- time Frame
- up to 470 days
- title
- Duration of Response
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
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