NCT06024174 · OUTCOME
Part 2- Duration of Response (DOR) Assessed by BICR as Per RECIST v1.1
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
- From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)
What was measured
Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only
Groups in this outcome
Part 2A
Part 2A were planned to evaluate BMS-986466 in combination with adagrasib in KRAS G12C-mutant (G12C inhibitor treatment-naïve) NSCLC participants.
Part 2B
Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
| Group | Source count |
|---|---|
| Part 2A | 0 |
| Part 2B | 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 objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- groups
- description
- Part 2A were planned to evaluate BMS-986466 in combination with adagrasib in KRAS G12C-mutant (G12C inhibitor treatment-naïve) NSCLC participants.
- id
- OG000
- title
- Part 2A
- description
- Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
- id
- OG001
- title
- Part 2B
- population Description
- Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only
- reporting Status
- POSTED
- time Frame
- From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)
- title
- Part 2- Duration of Response (DOR) Assessed by BICR as Per RECIST v1.1
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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