NCT02366143 · OUTCOME
OS Rates at Years 1 and 2 in Arm B Versus Arm C
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to 2 years or death, whichever occurs first.
What was measured
OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
Analysis population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.
Groups in this outcome
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
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 B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 235 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 196 |
|---|
Reported measurements
1-Year Teff-high WT Population
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 105 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 71 |
|---|
Values in Percentage · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 68.63 | Not reported | 61.28 | 75.98 | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 58.74 | Not reported | 50.03 | 67.45 | Not reported |
|---|
1-Year ITT-WT Population
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 235 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 196 |
|---|
Values in Percentage · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 67.32 | Not reported | 62.41 | 72.22 | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 60.63 | Not reported | 55.34 | 65.93 | Not reported |
|---|
2-Year Teff-high WT Population
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 21 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 15 |
|---|
Values in Percentage · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 52.03 | Not reported | 43.12 | 60.94 | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 41.70 | Not reported | 31.55 | 51.85 | Not reported |
|---|
2-Year ITT-WT Population
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 34 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 29 |
|---|
Values in Percentage · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 43.42 | Not reported | 36.94 | 49.90 | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 33.71 | Not reported | 27.44 | 39.98 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.90
- group Description
- 1-Year ITT-WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0697
- param Type
- Difference in Event Free Rate
- param Value
- 6.68
- statistical Method
- Z-test
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.73
- group Description
- 2-Year ITT-WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0347
- param Type
- Difference in Event Free Rate
- param Value
- 9.71
- statistical Method
- Z-test
- ci Lower Limit
- -1.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.29
- group Description
- 1-Year Teff-high WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0890
- param Type
- Difference in Event Free Rate
- param Value
- 9.89
- statistical Method
- Z-test
- ci Lower Limit
- -3.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.84
- group Description
- 2-Year Teff-high WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- OTHER
- p Value
- 0.1336
- param Type
- Difference in Event Free Rate
- param Value
- 10.34
- statistical Method
- Z-test
Complete source fields
- analyses
- ci Lower Limit
- -0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.90
- group Description
- 1-Year ITT-WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0697
- param Type
- Difference in Event Free Rate
- param Value
- 6.68
- statistical Method
- Z-test
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.73
- group Description
- 2-Year ITT-WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0347
- param Type
- Difference in Event Free Rate
- param Value
- 9.71
- statistical Method
- Z-test
- ci Lower Limit
- -1.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.29
- group Description
- 1-Year Teff-high WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0890
- param Type
- Difference in Event Free Rate
- param Value
- 9.89
- statistical Method
- Z-test
- ci Lower Limit
- -3.17
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.84
- group Description
- 2-Year Teff-high WT Population
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- OTHER
- p Value
- 0.1336
- param Type
- Difference in Event Free Rate
- param Value
- 10.34
- statistical Method
- Z-test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61.28
- upper Limit
- 75.98
- value
- 68.63
- group Id
- OG001
- lower Limit
- 50.03
- upper Limit
- 67.45
- value
- 58.74
- denoms
- counts
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 71
- units
- Participants
- title
- 1-Year Teff-high WT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.41
- upper Limit
- 72.22
- value
- 67.32
- group Id
- OG001
- lower Limit
- 55.34
- upper Limit
- 65.93
- value
- 60.63
- denoms
- counts
- group Id
- OG000
- value
- 235
- group Id
- OG001
- value
- 196
- units
- Participants
- title
- 1-Year ITT-WT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.12
- upper Limit
- 60.94
- value
- 52.03
- group Id
- OG001
- lower Limit
- 31.55
- upper Limit
- 51.85
- value
- 41.70
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- 2-Year Teff-high WT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.94
- upper Limit
- 49.90
- value
- 43.42
- group Id
- OG001
- lower Limit
- 27.44
- upper Limit
- 39.98
- value
- 33.71
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 29
- units
- Participants
- title
- 2-Year ITT-WT Population
- denoms
- counts
- group Id
- OG000
- value
- 235
- group Id
- OG001
- value
- 196
- units
- Participants
- description
- OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
- id
- OG000
- title
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- description
- Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
- id
- OG001
- title
- Arm C (Bevacizumab+Paclitaxel+Carboplatin)
- param Type
- NUMBER
- population Description
- Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.
- reporting Status
- POSTED
- time Frame
- Baseline to 2 years or death, whichever occurs first.
- title
- OS Rates at Years 1 and 2 in Arm B Versus Arm C
- type
- SECONDARY
- unit Of Measure
- Percentage
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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