NCT02367781 · OUTCOME
Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population
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
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 35 months after first patient enrolled, years 1 and 2 reported
What was measured
The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. 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: 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 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) | 230 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 111 |
|---|
Reported measurements
Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 230 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 111 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 68.56 | Not reported | 62.46 | 74.66 | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 61.86 | Not reported | 52.55 | 71.17 | Not reported |
|---|
Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 230 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 111 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 44.63 | Not reported | 35.99 | 53.27 | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 35.98 | Not reported | 23.25 | 48.72 | Not reported |
|---|
Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT WT
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 216 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 107 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 68.84 | Not reported | 62.56 | 75.13 | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 62.51 | Not reported | 53.07 | 71.94 | Not reported |
|---|
Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT WT
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 216 |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 107 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 44.02 | Not reported | 34.86 | 53.18 | Not reported |
|---|
| Arm B (Nab-Paclitaxel+Carboplatin) | 35.33 | Not reported | 22.06 | 48.60 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -4.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.83
- group Description
- Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2385
- param Type
- Difference in Event Free Rate
- param Value
- 6.69
- statistical Method
- Z-test
- ci Lower Limit
- -6.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.03
- group Description
- Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2710
- param Type
- Difference in Event Free Rate
- param Value
- 8.64
- statistical Method
- Z-test
- ci Lower Limit
- -5.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.67
- group Description
- Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2733
- param Type
- Difference in Event Free Rate
- param Value
- 6.34
- statistical Method
- Z-test
- ci Lower Limit
- -7.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.81
- group Description
- Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2909
- param Type
- Difference in Event Free Rate
- param Value
- 8.69
- statistical Method
- Z-test
Complete source fields
- analyses
- ci Lower Limit
- -4.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.83
- group Description
- Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2385
- param Type
- Difference in Event Free Rate
- param Value
- 6.69
- statistical Method
- Z-test
- ci Lower Limit
- -6.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.03
- group Description
- Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2710
- param Type
- Difference in Event Free Rate
- param Value
- 8.64
- statistical Method
- Z-test
- ci Lower Limit
- -5.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.67
- group Description
- Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2733
- param Type
- Difference in Event Free Rate
- param Value
- 6.34
- statistical Method
- Z-test
- ci Lower Limit
- -7.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.81
- group Description
- Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2909
- param Type
- Difference in Event Free Rate
- param Value
- 8.69
- statistical Method
- Z-test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.46
- upper Limit
- 74.66
- value
- 68.56
- group Id
- OG001
- lower Limit
- 52.55
- upper Limit
- 71.17
- value
- 61.86
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 111
- units
- Participants
- title
- Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.99
- upper Limit
- 53.27
- value
- 44.63
- group Id
- OG001
- lower Limit
- 23.25
- upper Limit
- 48.72
- value
- 35.98
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 111
- units
- Participants
- title
- Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.56
- upper Limit
- 75.13
- value
- 68.84
- group Id
- OG001
- lower Limit
- 53.07
- upper Limit
- 71.94
- value
- 62.51
- denoms
- counts
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT WT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.86
- upper Limit
- 53.18
- value
- 44.02
- group Id
- OG001
- lower Limit
- 22.06
- upper Limit
- 48.60
- value
- 35.33
- denoms
- counts
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 107
- units
- Participants
- title
- Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT WT
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 111
- units
- Participants
- description
- The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. 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
- NUMBER
- population Description
- PD-L1 Expression Population and PD-L1 Expression WT Population
- reporting Status
- POSTED
- time Frame
- Up to 35 months after first patient enrolled, years 1 and 2 reported
- title
- Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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