TriangleNCT02367781 · OUTCOME
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) 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
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 35 months after first subject enrolled
What was measured
ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. 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. PD-L1 expression WT population is defined as 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) | 479 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 237 |
Reported measurements
ITT Population
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 479 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 237 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 59.1 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 42.2 | Not reported | Not reported | Not reported | Not reported |
TC1/2/3 or IC1/2/3 ITT WT Population
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 215 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 106 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 65.6 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 46.2 | Not reported | Not reported | Not reported | Not reported |
TC1/2/3 or IC1/2/3 ITT Population
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 229 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 109 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 64.6 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 45.0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 8.90
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.88
- estimate Comment
- Wald with Continuity Correction
- group Description
- ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Unstratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Difference in Response Rate
- param Value
- 16.89
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 1.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.56
- group Description
- TC1/2/3 or IC1/2/3 ITT WT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 2.22
- ci Lower Limit
- 1.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.51
- group Description
- TC1/2/3 or IC1/2/3 ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0007
- param Type
- Odds Ratio (OR)
- param Value
- 2.21
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 8.90
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.88
- estimate Comment
- Wald with Continuity Correction
- group Description
- ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Unstratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Difference in Response Rate
- param Value
- 16.89
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 1.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.56
- group Description
- TC1/2/3 or IC1/2/3 ITT WT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 2.22
- ci Lower Limit
- 1.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.51
- group Description
- TC1/2/3 or IC1/2/3 ITT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0007
- param Type
- Odds Ratio (OR)
- param Value
- 2.21
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 59.1
- group Id
- OG001
- value
- 42.2
- denoms
- counts
- group Id
- OG000
- value
- 479
- group Id
- OG001
- value
- 237
- units
- Participants
- title
- ITT Population
- categories
- measurements
- group Id
- OG000
- value
- 65.6
- group Id
- OG001
- value
- 46.2
- denoms
- counts
- group Id
- OG000
- value
- 215
- group Id
- OG001
- value
- 106
- units
- Participants
- title
- TC1/2/3 or IC1/2/3 ITT WT Population
- categories
- measurements
- group Id
- OG000
- value
- 64.6
- group Id
- OG001
- value
- 45.0
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 109
- units
- Participants
- title
- TC1/2/3 or IC1/2/3 ITT Population
- denoms
- counts
- group Id
- OG000
- value
- 479
- group Id
- OG001
- value
- 237
- units
- Participants
- description
- ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. 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. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
- 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
- NUMBER
- 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
- Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) 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
- Percentage of participants
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Preserved source evidence · Not medical advice