TriangleNCT05722015 · OUTCOME
Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg·day/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)
What was measured
AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.
Analysis population: All randomized participants who received a dose in Cycle 1 with at least 1 valid postdose pharmacokinetic (PK) sample available in Cycle 1 and for whom a model-based assessment of AUC0-6 weeks could be made.
Groups in this outcome
Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy
Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy
Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.
| Group | Source count |
|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | 245 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | 126 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | 1633.24 | 40.41 | Not reported | Not reported | Not reported |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | 1437.58 | 26.23 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 96
- ci Upper Limit
- 1.22
- estimate Comment
- GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority margin is 0.8.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- <0.00001
- param Type
- Geometric Mean Ratio (GMR)
- param Value
- 1.14
- statistical Comment
- One-sided p-value was calculated using the Welch's t test.
- statistical Method
- Welch's t test
Complete source fields
- analyses
- ci Lower Limit
- 1.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 96
- ci Upper Limit
- 1.22
- estimate Comment
- GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority margin is 0.8.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- <0.00001
- param Type
- Geometric Mean Ratio (GMR)
- param Value
- 1.14
- statistical Comment
- One-sided p-value was calculated using the Welch's t test.
- statistical Method
- Welch's t test
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 40.41
- value
- 1633.24
- group Id
- OG001
- spread
- 26.23
- value
- 1437.58
- denoms
- counts
- group Id
- OG000
- value
- 245
- group Id
- OG001
- value
- 126
- units
- Participants
- description
- AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
- id
- OG000
- title
- Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy
- description
- Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.
- id
- OG001
- title
- Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy
- param Type
- GEOMETRIC_MEAN
- population Description
- All randomized participants who received a dose in Cycle 1 with at least 1 valid postdose pharmacokinetic (PK) sample available in Cycle 1 and for whom a model-based assessment of AUC0-6 weeks could be made.
- reporting Status
- POSTED
- time Frame
- Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)
- title
- Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose
- type
- PRIMARY
- unit Of Measure
- μg·day/mL
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Preserved source evidence · Not medical advice