TriangleNCT02578680 · OUTCOME
Overall Survival (OS)
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 21 months
What was measured
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS is presented.
Analysis population: The analysis population consisted of all randomized participants.
Groups in this outcome
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed
Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
Control
Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
| Group | Source count |
|---|---|
| Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | 410 |
| Control | 206 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | NA | Not reported | NA | NA | NA=Median OS not reached NA=Lower Limit OS not reached NA=Upper Limit OS not reached |
| Control | 11.3 | Not reported | 8.7 | 15.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.64
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.00001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.49
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.64
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.00001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.49
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA=Median OS not reached NA=Lower Limit OS not reached NA=Upper Limit OS not reached
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 8.7
- upper Limit
- 15.1
- value
- 11.3
- denoms
- counts
- group Id
- OG000
- value
- 410
- group Id
- OG001
- value
- 206
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
- id
- OG000
- title
- Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed
- description
- Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
- id
- OG001
- title
- Control
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 21 months
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice