TriangleNCT02367781 · OUTCOME
PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 35 months after first subject enrolled
What was measured
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Analysis population: ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
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)
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 | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 483 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 240 |
Reported measurements
ITT Population
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 483 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 240 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 7.0 | Not reported | 6.3 | 7.3 | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 5.6 | Not reported | 4.5 | 5.9 | Not reported |
TC1/2/3 or IC1/2/3 ITT Population
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 230 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 111 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 7.5 | Not reported | 7.0 | 9.1 | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 5.7 | Not reported | 4.5 | 6.6 | Not reported |
TC1/2/3 or IC1/2/3-WT ITT Population
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 216 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 107 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 7.5 | Not reported | 7.0 | 9.0 | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 5.9 | Not reported | 4.5 | 6.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.545
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.768
- group Description
- ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.647
- statistical Method
- Log Rank
- ci Lower Limit
- 0.432
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.728
- group Description
- TC1/2/3 or IC1/2/3-WT ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Unstratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.561
- statistical Method
- Log Rank
- ci Lower Limit
- 0.425
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.708
- group Description
- TC1/2/3 or IC1/2/3 ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Unstratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.549
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.545
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.768
- group Description
- ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.647
- statistical Method
- Log Rank
- ci Lower Limit
- 0.432
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.728
- group Description
- TC1/2/3 or IC1/2/3-WT ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Unstratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.561
- statistical Method
- Log Rank
- ci Lower Limit
- 0.425
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.708
- group Description
- TC1/2/3 or IC1/2/3 ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Unstratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.549
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.3
- upper Limit
- 7.3
- value
- 7.0
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 5.9
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 483
- group Id
- OG001
- value
- 240
- units
- Participants
- title
- ITT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- 9.1
- value
- 7.5
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 6.6
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 111
- units
- Participants
- title
- TC1/2/3 or IC1/2/3 ITT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- 9.0
- value
- 7.5
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 6.6
- value
- 5.9
- denoms
- counts
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- TC1/2/3 or IC1/2/3-WT ITT Population
- denoms
- counts
- group Id
- OG000
- value
- 483
- group Id
- OG001
- value
- 240
- units
- Participants
- description
- PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
- dispersion Type
- 95% Confidence Interval
- 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)
- param Type
- MEDIAN
- population Description
- ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
- reporting Status
- POSTED
- time Frame
- Up to approximately 35 months after first subject enrolled
- title
- PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice