NCT03915951 · OUTCOME
Number of Participants With Notable ECG (QTcF) Values
An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer · Source last updated 2026-03-24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Screening, Cycle 1 Day 1, Cycle 2 Day 1 ±3 Days, Every 12 Weeks ±7 Days, and EOT ±3 Days (Up to 36 Months)
What was measured
The QTcF increase from baseline \>30/60 msec and new QTcF \>450/480/500 msec were defined as clinically notable ECG criteria. Triplicate ECG measurements were obtained. For new abnormal post-baseline values, the table below presents the number of participants with both non-missing baseline and post-baseline values, and baseline values not meeting the criteria. For abnormal changes from baseline, the table below presents the number of participants with both non-missing baseline and post-baseline evaluations. Baseline was defined as the average of the machine-read triplicate ECG measurements taken pre-dose on Day 1. Change from baseline was post-baseline - baseline values.
Analysis population: Safety Analysis Set included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
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.
Total
Sum of all participants in the Study C4221008 (ARRAY-818-202)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 59 |
|---|
| Previously Treated | 39 |
|---|
| Total | 98 |
|---|
Reported measurements
New QTcF >450 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 54 |
|---|
| Previously Treated | 31 |
|---|
| Total | 85 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment-Naive | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Previously Treated | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
New QTcF >480 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 57 |
|---|
| Previously Treated | 37 |
|---|
| Total | 94 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment-Naive | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Previously Treated | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
New QTcF >500 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 58 |
|---|
| Previously Treated | 37 |
|---|
| Total | 95 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment-Naive | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Previously Treated | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcF Increase from baseline >30 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 58 |
|---|
| Previously Treated | 38 |
|---|
| Total | 96 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment-Naive | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Previously Treated | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcF Increase from baseline >60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 58 |
|---|
| Previously Treated | 38 |
|---|
| Total | 96 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment-Naive | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Previously Treated | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 85
- units
- Participants
- title
- New QTcF >450 msec
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 94
- units
- Participants
- title
- New QTcF >480 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 95
- units
- Participants
- title
- New QTcF >500 msec
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 29
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 96
- units
- Participants
- title
- QTcF Increase from baseline >30 msec
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 96
- units
- Participants
- title
- QTcF Increase from baseline >60 msec
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 98
- units
- Participants
- description
- The QTcF increase from baseline \>30/60 msec and new QTcF \>450/480/500 msec were defined as clinically notable ECG criteria. Triplicate ECG measurements were obtained. For new abnormal post-baseline values, the table below presents the number of participants with both non-missing baseline and post-baseline values, and baseline values not meeting the criteria. For abnormal changes from baseline, the table below presents the number of participants with both non-missing baseline and post-baseline evaluations. Baseline was defined as the average of the machine-read triplicate ECG measurements taken pre-dose on Day 1. Change from baseline was post-baseline - baseline values.
- 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
- description
- Sum of all participants in the Study C4221008 (ARRAY-818-202)
- id
- OG002
- title
- Total
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
- reporting Status
- POSTED
- time Frame
- Screening, Cycle 1 Day 1, Cycle 2 Day 1 ±3 Days, Every 12 Weeks ±7 Days, and EOT ±3 Days (Up to 36 Months)
- title
- Number of Participants With Notable ECG (QTcF) Values
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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