TriangleNCT03505710 · OUTCOME
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review 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 screening, up to 36 months (data cut-off)
What was measured
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.
Analysis population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 December 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HER2 Overexpressing | 26.5 | Not reported | 15.0 | 41.1 | Not reported |
| Cohort 1a: HER2 Overexpressing | 34.1 | Not reported | 16.1 | 45.5 | Not reported |
| Cohort 2: HER2 Mutated | 54.9 | Not reported | 44.2 | 65.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.0
- upper Limit
- 41.1
- value
- 26.5
- group Id
- OG001
- lower Limit
- 16.1
- upper Limit
- 45.5
- value
- 34.1
- group Id
- OG002
- lower Limit
- 44.2
- upper Limit
- 65.4
- value
- 54.9
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR 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
- Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 December 2021.
- reporting Status
- POSTED
- time Frame
- From screening, up to 36 months (data cut-off)
- title
- Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice