TriangleNCT03505710 · OUTCOME
Percentage of Participants With Disease Control Rate (DCR) 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
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose, up to 36 months (data cut-off)
What was measured
Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported.
Analysis population: Disease control rate 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 | 68.9 | Not reported | 53.4 | 81.8 | Not reported |
| Cohort 1a: HER2 Overexpressing | 77.5 | Not reported | 61.6 | 89.2 | Not reported |
| Cohort 2: HER2 Mutated | 93.0 | Not reported | 85.4 | 97.4 | Not reported |
Investigator Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HER2 Overexpressing | 75.5 | Not reported | 61.1 | 86.7 | Not reported |
| Cohort 1a: HER2 Overexpressing | 78.0 | Not reported | 62.4 | 89.4 | Not reported |
| Cohort 2: HER2 Mutated | 94.5 | Not reported | 87.6 | 98.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.4
- upper Limit
- 81.8
- value
- 68.9
- group Id
- OG001
- lower Limit
- 61.6
- upper Limit
- 89.2
- value
- 77.5
- group Id
- OG002
- lower Limit
- 85.4
- upper Limit
- 97.4
- value
- 93.0
- title
- Independent Central Review
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61.1
- upper Limit
- 86.7
- value
- 75.5
- group Id
- OG001
- lower Limit
- 62.4
- upper Limit
- 89.4
- value
- 78.0
- group Id
- OG002
- lower Limit
- 87.6
- upper Limit
- 98.2
- value
- 94.5
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR 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
- NUMBER
- population Description
- Disease control rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
- reporting Status
- POSTED
- time Frame
- From first dose, up to 36 months (data cut-off)
- title
- Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice