TriangleNCT04685135 · OUTCOME
Objective Response Rate (ORR) 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)
What was measured
Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). 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 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 | 31.9 | Not reported | 26.7 | 37.5 | Not reported |
| Docetaxel | 9.2 | Not reported | 5.1 | 15.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.56
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 4.68
- statistical Method
- Cochran Mantel Haenszel chi-square test
Complete source fields
- analyses
- ci Lower Limit
- 2.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.56
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 4.68
- statistical Method
- Cochran Mantel Haenszel chi-square test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.7
- upper Limit
- 37.5
- value
- 31.9
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 15.0
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 152
- units
- Participants
- description
- Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). 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
- NUMBER
- population Description
- Intent-To-Treat Population includes all participants who are randomized into this study.
- reporting Status
- POSTED
- time Frame
- From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)
- title
- Objective Response Rate (ORR) as Per Blinded Independent Central Review
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice