TriangleNCT02998528 · OUTCOME
Event-Free Survival (EFS)
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
- From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
What was measured
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Analysis population: All concurrently randomized participants in Arm C and Arm B
Groups in this outcome
Arm B: Platinum Doublet Chemo
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
Arm C: Nivo 360 mg + Platinum Doublet Chemo
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
| Group | Source count |
|---|---|
| Arm B: Platinum Doublet Chemo | 179 |
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B: Platinum Doublet Chemo | 20.80 | Not reported | 14.03 | 26.71 | Not reported |
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 31.57 | Not reported | 30.16 | NA | Insufficient number of participants with events |
Source statistical analyses
- ci Lower Limit
- 0.43
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.38
- ci Upper Limit
- 0.91
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0052
- param Type
- Cox Proportional Hazard
- param Value
- 0.63
- statistical Comment
- Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.43
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.38
- ci Upper Limit
- 0.91
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0052
- param Type
- Cox Proportional Hazard
- param Value
- 0.63
- statistical Comment
- Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.03
- upper Limit
- 26.71
- value
- 20.80
- comment
- Insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 30.16
- upper Limit
- NA
- value
- 31.57
- denoms
- counts
- group Id
- OG000
- value
- 179
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- OG000
- title
- Arm B: Platinum Doublet Chemo
- description
- Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- OG001
- title
- Arm C: Nivo 360 mg + Platinum Doublet Chemo
- param Type
- MEDIAN
- population Description
- All concurrently randomized participants in Arm C and Arm B
- reporting Status
- POSTED
- time Frame
- From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
- title
- Event-Free Survival (EFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice