NCT02367781 · OUTCOME
Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months)
Analysis population: The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.
Groups in this outcome
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Arm B (Nab-Paclitaxel+Carboplatin Crossover)
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 30 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 20 |
|---|
Reported measurements
Cycle 1 Day 1 Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 29 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 19 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | NA | NA | Not reported | Not reported | Below the level of detection. |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | NA | NA | Not reported | Not reported | Below the level of detection. |
|---|
Cycle 1 Day 1 Before End of Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 27 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 15 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 3520 | 2210 | Not reported | Not reported | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 2530 | 1420 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 1 Post Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 25 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 17 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 307 | 153 | Not reported | Not reported | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 417 | 217 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1 Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 23 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 16 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | NA | NA | Not reported | Not reported | Below the threshold of the assay. |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | NA | NA | Not reported | Not reported | Below the threshold of the assay. |
|---|
Cycle 3 Day 1 Before End of Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 17 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 10 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 4480 | 3520 | Not reported | Not reported | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 2030 | 1690 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1 Post Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 18 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 15 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 357 | 253 | Not reported | Not reported | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin Crossover) | 447 | 322 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Below the level of detection.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Below the level of detection.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Cycle 1 Day 1 Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2210
- value
- 3520
- group Id
- OG001
- spread
- 1420
- value
- 2530
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Cycle 1 Day 1 Before End of Infusion
- categories
- measurements
- group Id
- OG000
- spread
- 153
- value
- 307
- group Id
- OG001
- spread
- 217
- value
- 417
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Cycle 1 Day 1 Post Infusion
- categories
- measurements
- comment
- Below the threshold of the assay.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Below the threshold of the assay.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Cycle 3 Day 1 Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 3520
- value
- 4480
- group Id
- OG001
- spread
- 1690
- value
- 2030
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- Cycle 3 Day 1 Before End of Infusion
- categories
- measurements
- group Id
- OG000
- spread
- 253
- value
- 357
- group Id
- OG001
- spread
- 322
- value
- 447
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Cycle 3 Day 1 Post Infusion
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 20
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- id
- OG000
- title
- Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
- description
- Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
- id
- OG001
- title
- Arm B (Nab-Paclitaxel+Carboplatin Crossover)
- param Type
- MEAN
- population Description
- The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.
- reporting Status
- POSTED
- time Frame
- Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months)
- title
- Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle