TriangleNCT03425643 · OUTCOME
Major Pathological Response (mPR) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
What was measured
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented.
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 | 30.2 | Not reported | 25.7 | 35.0 | Not reported |
| NAC + Neoadjuvant/Adjuvant Placebo | 11.0 | Not reported | 8.1 | 14.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 13.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.7
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- non Inferiority Type
- OTHER
- p Value
- <0.00001
- param Type
- Difference in Percentage
- param Value
- 19.2
- statistical Method
- Stratified Miettinen and Nurminen
Complete source fields
- analyses
- ci Lower Limit
- 13.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.7
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- non Inferiority Type
- OTHER
- p Value
- <0.00001
- param Type
- Difference in Percentage
- param Value
- 19.2
- statistical Method
- Stratified Miettinen and Nurminen
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.7
- upper Limit
- 35.0
- value
- 30.2
- group Id
- OG001
- lower Limit
- 8.1
- upper Limit
- 14.5
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 397
- group Id
- OG001
- value
- 400
- units
- Participants
- description
- mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented.
- 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
- NUMBER
- population Description
- The analysis population consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
- title
- Major Pathological Response (mPR) Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice