TriangleNCT03915951 · OUTCOME
Disease Control Rate (DCR) by IRR and Investigator Assessments
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
- After 24 Weeks (≥168 days) from the date of first dose of study intervention
What was measured
DCR was defined as the percentage of participants who had achieved a confirmed overall response of CR, PR or stable disease (SD), as determined by Investigator review of radiographic disease assessments and IRR per RECIST version 1.1 after 24 weeks (≥168 days) from the date of first dose of study intervention. CR was defined by the disappearance of all non-lymph node target lesions and complete disappearance of all non-target lesions. PR was defined by a 30% or more decrease in SOD of target lesions, taking as reference the baseline SOD. SD was assigned when neither sufficient shrinkage to qualify for CR or PR, nor sufficient increase to qualify for PD was observed, taking as reference the nadir. DCR was calculated along with the exact 2-sided Clopper-Pearson 95% CI.
Analysis population: Analysis population included all participants who received at least 1 dose of study intervention.
Groups in this outcome
Treatment-Naive
Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
Previously Treated
Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
| Group | Source count |
|---|---|
| Treatment-Naive | 59 |
| Previously Treated | 39 |
Reported measurements
DCR After 24 Weeks by IRR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 64.4 | Not reported | 50.9 | 76.4 | Not reported |
| Previously Treated | 41.0 | Not reported | 25.6 | 57.9 | Not reported |
DCR After 24 Weeks by Investigator Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 67.8 | Not reported | 54.4 | 79.4 | Not reported |
| Previously Treated | 48.7 | Not reported | 32.4 | 65.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.9
- upper Limit
- 76.4
- value
- 64.4
- group Id
- OG001
- lower Limit
- 25.6
- upper Limit
- 57.9
- value
- 41.0
- title
- DCR After 24 Weeks by IRR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.4
- upper Limit
- 79.4
- value
- 67.8
- group Id
- OG001
- lower Limit
- 32.4
- upper Limit
- 65.2
- value
- 48.7
- title
- DCR After 24 Weeks by Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- DCR was defined as the percentage of participants who had achieved a confirmed overall response of CR, PR or stable disease (SD), as determined by Investigator review of radiographic disease assessments and IRR per RECIST version 1.1 after 24 weeks (≥168 days) from the date of first dose of study intervention. CR was defined by the disappearance of all non-lymph node target lesions and complete disappearance of all non-target lesions. PR was defined by a 30% or more decrease in SOD of target lesions, taking as reference the baseline SOD. SD was assigned when neither sufficient shrinkage to qualify for CR or PR, nor sufficient increase to qualify for PD was observed, taking as reference the nadir. DCR was calculated along with the exact 2-sided Clopper-Pearson 95% CI.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- OG000
- title
- Treatment-Naive
- description
- Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- OG001
- title
- Previously Treated
- param Type
- NUMBER
- population Description
- Analysis population included all participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- After 24 Weeks (≥168 days) from the date of first dose of study intervention
- title
- Disease Control Rate (DCR) by IRR and Investigator Assessments
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice