TriangleNCT03505710 · OUTCOME
Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
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 date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off)
What was measured
Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported.
Analysis population: Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
Groups in this outcome
Cohort 1: HER2 Overexpressing
Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Cohort 1a: HER2 Overexpressing
Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Cohort 2: HER2 Mutated
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
| Group | Source count |
|---|---|
| Cohort 1: HER2 Overexpressing | 49 |
| Cohort 1a: HER2 Overexpressing | 41 |
| Cohort 2: HER2 Mutated | 91 |
Reported measurements
Independent Central Review
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HER2 Overexpressing | 5.7 | Not reported | 2.8 | 7.2 | Not reported |
| Cohort 1a: HER2 Overexpressing | 6.7 | Not reported | 4.5 | NA | Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events. |
| Cohort 2: HER2 Mutated | 8.2 | Not reported | 6.0 | 11.9 | Not reported |
Investigator Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HER2 Overexpressing | 5.7 | Not reported | 3.8 | 7.2 | Not reported |
| Cohort 1a: HER2 Overexpressing | 7.2 | Not reported | 4.1 | 8.4 | Not reported |
| Cohort 2: HER2 Mutated | 9.3 | Not reported | 7.1 | 14.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 7.2
- value
- 5.7
- comment
- Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- NA
- value
- 6.7
- group Id
- OG002
- lower Limit
- 6.0
- upper Limit
- 11.9
- value
- 8.2
- title
- Independent Central Review
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.8
- upper Limit
- 7.2
- value
- 5.7
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 8.4
- value
- 7.2
- group Id
- OG002
- lower Limit
- 7.1
- upper Limit
- 14.0
- value
- 9.3
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
- id
- OG000
- title
- Cohort 1: HER2 Overexpressing
- description
- Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
- id
- OG001
- title
- Cohort 1a: HER2 Overexpressing
- description
- Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
- id
- OG002
- title
- Cohort 2: HER2 Mutated
- param Type
- MEDIAN
- population Description
- Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
- reporting Status
- POSTED
- time Frame
- From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off)
- title
- Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice