TriangleNCT04685135 · OUTCOME
Duration of Response (DOR) 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
- First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)
What was measured
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Analysis population: Intent-To-Treat Population with Confirmed CR or PR. 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 | 96 |
| Docetaxel | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 8.31 | Not reported | 6.05 | 10.35 | Not reported |
| Docetaxel | 5.36 | Not reported | 2.86 | 8.54 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.05
- upper Limit
- 10.35
- value
- 8.31
- group Id
- OG001
- lower Limit
- 2.86
- upper Limit
- 8.54
- value
- 5.36
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 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 with Confirmed CR or PR. Intent-To-Treat Population includes all participants who are randomized into this study.
- reporting Status
- POSTED
- time Frame
- First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)
- title
- Duration of Response (DOR) as Per Blinded Independent Central Review
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice