TriangleNCT03425643 · 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 5 years
What was measured
OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).
Analysis population: The analysis population consisted of all randomized participants.
Groups in this outcome
NAC + Neoadjuvant/Adjuvant Pembrolizumab
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].
NAC + Neoadjuvant/Adjuvant Placebo
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
| Group | Source count |
|---|---|
| NAC + Neoadjuvant/Adjuvant Pembrolizumab | 397 |
| NAC + Neoadjuvant/Adjuvant Placebo | 400 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NAC + Neoadjuvant/Adjuvant Pembrolizumab | NA | Not reported | NA | NA | NA= Median OS, lower limit, and upper limit not reached at time of data cut off |
| NAC + Neoadjuvant/Adjuvant Placebo | 52.4 | Not reported | 45.7 | NA | NA= Upper limit not reached at time of data cut off |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.93
- estimate Comment
- Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00517
- p Value Comment
- One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.72
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.93
- estimate Comment
- Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00517
- p Value Comment
- One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.72
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA= Median OS, lower limit, and upper limit not reached at time of data cut off
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA= Upper limit not reached at time of data cut off
- group Id
- OG001
- lower Limit
- 45.7
- upper Limit
- NA
- value
- 52.4
- denoms
- counts
- group Id
- OG000
- value
- 397
- group Id
- OG001
- value
- 400
- units
- Participants
- description
- OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].
- id
- OG000
- title
- NAC + Neoadjuvant/Adjuvant Pembrolizumab
- description
- Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
- id
- OG001
- title
- NAC + Neoadjuvant/Adjuvant Placebo
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 5 years
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice