TriangleNCT03765918 · OUTCOME
EFS in Participants With PD-L1 CPS ≥1
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 ~66 months
What was measured
EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.
Analysis population: Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.
Groups in this outcome
Pembrolizumab + Standard of Care (SOC)
Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
Standard of Care (SOC)
Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
| Group | Source count |
|---|---|
| Pembrolizumab + Standard of Care (SOC) | 347 |
| Standard of Care (SOC) | 335 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Standard of Care (SOC) | 59.7 | Not reported | 37.9 | NA | NA = upper limit not reached due to insufficient number of participants with an event. |
| Standard of Care (SOC) | 29.6 | Not reported | 19.5 | 41.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.89
- group Ids
- OG000
- OG001
- non Inferiority Comment
- HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00140
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Comment
- One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.
- statistical Method
- Stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.89
- group Ids
- OG000
- OG001
- non Inferiority Comment
- HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00140
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Comment
- One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.
- statistical Method
- Stratified Log Rank
- classes
- categories
- measurements
- comment
- NA = upper limit not reached due to insufficient number of participants with an event.
- group Id
- OG000
- lower Limit
- 37.9
- upper Limit
- NA
- value
- 59.7
- group Id
- OG001
- lower Limit
- 19.5
- upper Limit
- 41.9
- value
- 29.6
- denoms
- counts
- group Id
- OG000
- value
- 347
- group Id
- OG001
- value
- 335
- units
- Participants
- description
- EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG000
- title
- Pembrolizumab + Standard of Care (SOC)
- description
- Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG001
- title
- Standard of Care (SOC)
- param Type
- MEDIAN
- population Description
- Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to ~66 months
- title
- EFS in Participants With PD-L1 CPS ≥1
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice