TriangleNCT02853305 · OUTCOME
Pembro Combo vs Chemo: 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 42 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 final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
Analysis population: All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Groups in this outcome
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
| Group | Source count |
|---|---|
| Pembrolizumab + ST Chemotherapy (Pembro Combo) | 351 |
| Pembrolizumab (Pembro) | 0 |
| ST Chemotherapy (Chemo) | 352 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + ST Chemotherapy (Pembro Combo) | 17.0 | Not reported | 14.5 | 19.5 | Not reported |
| ST Chemotherapy (Chemo) | 14.3 | Not reported | 12.3 | 16.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.02
- group Description
- OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0407
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Comment
- The treatment difference in OS was assessed by the stratified log-rank test.
- statistical Method
- Stratified Log-Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.02
- group Description
- OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0407
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Comment
- The treatment difference in OS was assessed by the stratified log-rank test.
- statistical Method
- Stratified Log-Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.5
- upper Limit
- 19.5
- value
- 17.0
- group Id
- OG002
- lower Limit
- 12.3
- upper Limit
- 16.7
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 351
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 352
- 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 final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
- id
- OG000
- title
- Pembrolizumab + ST Chemotherapy (Pembro Combo)
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
- id
- OG001
- title
- Pembrolizumab (Pembro)
- description
- Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
- id
- OG002
- title
- ST Chemotherapy (Chemo)
- param Type
- MEDIAN
- population Description
- All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Pembro Combo vs Chemo: Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice