TriangleNCT02899299 · OUTCOME
Progression Free Survival (PFS) According to PD-L1 Expression Level
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
- From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
What was measured
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis. PFS is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
Analysis population: All PD-L1 evaluable participants with baseline expression \<1% or ≥1%
Groups in this outcome
Treatment A
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
Treatment B
Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
| Group | Source count |
|---|---|
| Treatment A | 289 |
| Treatment B | 297 |
Reported measurements
<1% PD-L1
| Group | Source count |
|---|---|
| Treatment A | 57 |
| Treatment B | 78 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A | 4.1 | Not reported | 2.7 | 5.6 | Not reported |
| Treatment B | 8.3 | Not reported | 7.0 | 11.1 | Not reported |
≥1% PD-L1
| Group | Source count |
|---|---|
| Treatment A | 232 |
| Treatment B | 219 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A | 7.0 | Not reported | 5.8 | 8.5 | Not reported |
| Treatment B | 7.1 | Not reported | 6.2 | 7.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.63
- group Description
- \< 1% PD-L1
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment A vs Treatment B
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.79
- ci Lower Limit
- 0.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- group Description
- ≥1% PD-L1
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment A vs Treatment B
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
Complete source fields
- analyses
- ci Lower Limit
- 1.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.63
- group Description
- \< 1% PD-L1
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment A vs Treatment B
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.79
- ci Lower Limit
- 0.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- group Description
- ≥1% PD-L1
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment A vs Treatment B
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- 5.6
- value
- 4.1
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 11.1
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 78
- units
- Participants
- title
- <1% PD-L1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- 8.5
- value
- 7.0
- group Id
- OG001
- lower Limit
- 6.2
- upper Limit
- 7.6
- value
- 7.1
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 219
- units
- Participants
- title
- ≥1% PD-L1
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 297
- units
- Participants
- description
- PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis. PFS is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
- id
- OG000
- title
- Treatment A
- description
- Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
- id
- OG001
- title
- Treatment B
- param Type
- MEDIAN
- population Description
- All PD-L1 evaluable participants with baseline expression \<1% or ≥1%
- reporting Status
- POSTED
- time Frame
- From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
- title
- Progression Free Survival (PFS) According to PD-L1 Expression Level
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice