NCT04607421 · OUTCOME

Phase 3: EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Visual Analogue Score (VAS) at Baseline and Week 72

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline and Week 72

What was measured

EQ-5D-5L is a standardized measure of health status. The EQ-5D-5L consisted of EQ-5D-5L descriptive system and the EQ VAS. For EQ VAS participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

Analysis population: The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Groups in this outcome

Phase 3: Arm A [EC]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

Phase 3: Arm B [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]

Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.

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
Phase 3: Arm A [EC]	130
Phase 3: Arm B [EC + mFOLFOX6]	197
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]	176

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Phase 3: Arm A [EC]	130
Phase 3: Arm B [EC + mFOLFOX6]	197
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]	176

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	70.4	19.76	Not reported	Not reported	Not reported
Phase 3: Arm B [EC + mFOLFOX6]	70.9	17.67	Not reported	Not reported	Not reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]	73.4	18.28	Not reported	Not reported	Not reported

Week 72

Analysis denominator · Participants

Group	Source count
Phase 3: Arm A [EC]	24
Phase 3: Arm B [EC + mFOLFOX6]	58
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]	10

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Arm A [EC]	78.7	16.19	Not reported	Not reported	Not reported
Phase 3: Arm B [EC + mFOLFOX6]	74.1	18.67	Not reported	Not reported	Not reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]	79.3	15.62	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
19.76
value
70.4
group Id
OG001
spread
17.67
value
70.9
group Id
OG002
spread
18.28
value
73.4
denoms
counts
group Id
OG000
value
130
group Id
OG001
value
197
group Id
OG002
value
176
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
16.19
value
78.7
group Id
OG001
spread
18.67
value
74.1
group Id
OG002
spread
15.62
value
79.3
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
58
group Id
OG002
value
10
units
Participants
title
Week 72

denoms

counts
group Id
OG000
value
130
group Id
OG001
value
197
group Id
OG002
value
176
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
id
OG000
title
Phase 3: Arm A [EC]
description
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
id
OG001
title
Phase 3: Arm B [EC + mFOLFOX6]
description
Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
id
OG002
title
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]

param Type

MEAN

population Description

The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

reporting Status

POSTED

time Frame

Baseline and Week 72

title

Phase 3: EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Visual Analogue Score (VAS) at Baseline and Week 72

type

SECONDARY

unit Of Measure

Units on a scale

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Preserved source evidence · Not medical advice