TriangleNCT04644237 · OUTCOME
Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
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
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
What was measured
Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. 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.
Analysis population: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization. From the Full Analysis Set, 47 participants had a confirmed CR or PR in T-DXd 5.4 mg/kg arm, and 28 participants in T-DXd 6.4 mg/kg arm
Groups in this outcome
Trastuzumab Deruxtecan 5.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
Trastuzumab Deruxtecan 6.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | 47 |
| Trastuzumab Deruxtecan 6.4 mg/kg | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan 5.4 mg/kg | 11.1 | Not reported | 8.3 | 15.5 | Not reported |
| Trastuzumab Deruxtecan 6.4 mg/kg | 12.9 | Not reported | 6.9 | 15.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 15.5
- value
- 11.1
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 15.4
- value
- 12.9
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- id
- OG000
- title
- Trastuzumab Deruxtecan 5.4 mg/kg
- description
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- id
- OG001
- title
- Trastuzumab Deruxtecan 6.4 mg/kg
- param Type
- MEDIAN
- population Description
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization. From the Full Analysis Set, 47 participants had a confirmed CR or PR in T-DXd 5.4 mg/kg arm, and 28 participants in T-DXd 6.4 mg/kg arm
- reporting Status
- POSTED
- time Frame
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- title
- Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice