NCT04914897 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 40
- group Id
- BG003
- value
- 29
- group Id
- BG004
- value
- 106
- units
- Participants
- groups
- description
- Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG000
- title
- Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
- description
- Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG001
- title
- Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
- description
- Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG002
- title
- Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
- description
- Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG003
- title
- Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.4
- value
- 65.3
- group Id
- BG001
- spread
- 8.4
- value
- 68.8
- group Id
- BG002
- spread
- 11.6
- value
- 63.6
- group Id
- BG003
- spread
- 10.7
- value
- 69.1
- group Id
- BG004
- spread
- 10.8
- value
- 66.3
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 35
- title
- Female
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 27
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 71
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 6
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 32
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 78
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 22
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies).
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 40
- group Id
- BG003
- value
- 29
- group Id
- BG004
- value
- 106
- units
- Participants
- groups
- description
- Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of \>=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG000
- title
- Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
- description
- Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG001
- title
- Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
- description
- Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG002
- title
- Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
- description
- Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
- id
- BG003
- title
- Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.4
- value
- 65.3
- group Id
- BG001
- spread
- 8.4
- value
- 68.8
- group Id
- BG002
- spread
- 11.6
- value
- 63.6
- group Id
- BG003
- spread
- 10.7
- value
- 69.1
- group Id
- BG004
- spread
- 10.8
- value
- 66.3
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 35
- title
- Female
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 27
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 71
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 6
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 32
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 78
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 22
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies).
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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