TriangleNCT04685135 · OUTCOME
Progression-Free Survival (PFS) as Per Blinded Independent Central Review
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 the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
What was measured
Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: Intent-To-Treat Population includes all participants who are randomized into this study.
Groups in this outcome
Adagrasib
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
Docetaxel
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
| Group | Source count |
|---|---|
| Adagrasib | 301 |
| Docetaxel | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 5.49 | Not reported | 4.53 | 6.67 | Not reported |
| Docetaxel | 3.84 | Not reported | 2.73 | 4.73 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Comment
- HR and CI are from stratified Cox proportional hazard model
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Comment
- HR and CI are from stratified Cox proportional hazard model
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.53
- upper Limit
- 6.67
- value
- 5.49
- group Id
- OG001
- lower Limit
- 2.73
- upper Limit
- 4.73
- value
- 3.84
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 152
- units
- Participants
- description
- Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
- id
- OG000
- title
- Adagrasib
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
- id
- OG001
- title
- Docetaxel
- param Type
- MEDIAN
- population Description
- Intent-To-Treat Population includes all participants who are randomized into this study.
- reporting Status
- POSTED
- time Frame
- From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
- title
- Progression-Free Survival (PFS) as Per Blinded Independent Central Review
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice