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NCT03052608 · OUTCOME

Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25

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: 95% Confidence Interval
Time frame: Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment

What was measured

The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status. There are 2 components to the EuroQol EQ-5D-5L: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a VAS. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) and higher scores indicate better health state.

Analysis population: "Number of Participants Analyzed" included all participants in the EQ-5D-5L PRO analysis population within each treatment group. "Number Analyzed" included all participants with at least a baseline and postbaseline assessment at the visit.

Groups in this outcome

Lorlatinib

Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

Crizotinib

Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

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
Lorlatinib	147
Crizotinib	138

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	143
Crizotinib	133

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.0	Not reported	3.33	8.72	Not reported
Crizotinib	3.1	Not reported	0.19	5.92	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	137
Crizotinib	124

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.0	Not reported	3.30	8.75	Not reported
Crizotinib	5.3	Not reported	2.37	8.18	Not reported

Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	133
Crizotinib	122

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.1	Not reported	3.71	10.41	Not reported
Crizotinib	5.6	Not reported	2.77	8.47	Not reported

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	130
Crizotinib	115

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	4.3	Not reported	0.39	8.13	Not reported
Crizotinib	5.1	Not reported	1.88	8.26	Not reported

Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	127
Crizotinib	105

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.5	Not reported	3.11	9.85	Not reported
Crizotinib	4.5	Not reported	1.08	7.91	Not reported

Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	122
Crizotinib	100

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	5.5	Not reported	1.95	9.13	Not reported
Crizotinib	4.0	Not reported	0.35	7.55	Not reported

Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	125
Crizotinib	94

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.7	Not reported	2.95	10.37	Not reported
Crizotinib	4.2	Not reported	0.63	7.68	Not reported

Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	120
Crizotinib	82

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.4	Not reported	2.47	10.33	Not reported
Crizotinib	3.9	Not reported	0.09	7.69	Not reported

Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	116
Crizotinib	74

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.2	Not reported	3.22	11.20	Not reported
Crizotinib	3.9	Not reported	-0.02	7.75	Not reported

Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	117
Crizotinib	73

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	8.1	Not reported	4.27	11.83	Not reported
Crizotinib	2.0	Not reported	-1.62	5.59	Not reported

Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	117
Crizotinib	61

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.6	Not reported	3.82	11.41	Not reported
Crizotinib	4.8	Not reported	0.95	8.59	Not reported

Cycle 13 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	114
Crizotinib	56

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.5	Not reported	3.91	11.11	Not reported
Crizotinib	5.8	Not reported	1.99	9.51	Not reported

Cycle 14 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	110
Crizotinib	48

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.7	Not reported	3.06	10.32	Not reported
Crizotinib	2.3	Not reported	-1.33	5.91	Not reported

Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	111
Crizotinib	43

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.1	Not reported	2.33	9.96	Not reported
Crizotinib	1.5	Not reported	-3.14	6.07	Not reported

Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	104
Crizotinib	39

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.9	Not reported	2.71	11.04	Not reported
Crizotinib	2.4	Not reported	-2.89	7.71	Not reported

Cycle 17 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	93
Crizotinib	32

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	8.3	Not reported	4.08	12.46	Not reported
Crizotinib	1.1	Not reported	-5.05	7.17	Not reported

Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	83
Crizotinib	29

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	8.7	Not reported	4.17	13.28	Not reported
Crizotinib	1.3	Not reported	-5.01	7.56	Not reported

Cycle 19 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	78
Crizotinib	23

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.8	Not reported	1.86	11.70	Not reported
Crizotinib	2.8	Not reported	-2.79	8.44	Not reported

Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	69
Crizotinib	19

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.9	Not reported	2.83	13.06	Not reported
Crizotinib	3.4	Not reported	-3.59	10.44	Not reported

Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	65
Crizotinib	17

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.2	Not reported	1.96	12.44	Not reported
Crizotinib	3.3	Not reported	-4.06	10.64	Not reported

Cycle 22 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	56
Crizotinib	14

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	4.5	Not reported	-0.51	9.48	Not reported
Crizotinib	1.9	Not reported	-6.69	10.54	Not reported

Cycle 23 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	48
Crizotinib	12

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	5.2	Not reported	-0.68	11.14	Not reported
Crizotinib	-0.6	Not reported	-10.97	9.81	Not reported

Cycle 24 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	44
Crizotinib	10

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	4.9	Not reported	-1.22	11.09	Not reported
Crizotinib	-3.0	Not reported	-21.43	15.43	Not reported

Cycle 25 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	39
Crizotinib	9

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	4.0	Not reported	-2.13	10.18	Not reported
Crizotinib	1.4	Not reported	-11.86	14.75	Not reported

Cycle 26 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	35
Crizotinib	9

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.9	Not reported	1.00	14.77	Not reported
Crizotinib	2.0	Not reported	-11.84	15.84	Not reported

Cycle 27 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	30
Crizotinib	7

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	4.6	Not reported	-2.37	11.57	Not reported
Crizotinib	3.0	Not reported	-12.79	18.79	Not reported

Cycle 28 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	23
Crizotinib	6

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	6.0	Not reported	-3.75	15.66	Not reported
Crizotinib	2.7	Not reported	-13.20	18.54	Not reported

Cycle 29Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	20
Crizotinib	5

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.4	Not reported	-3.78	18.48	Not reported
Crizotinib	8.2	Not reported	-11.18	27.58	Not reported

Cycle 30 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	14
Crizotinib	4

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	9.1	Not reported	-5.66	23.95	Not reported
Crizotinib	2.8	Not reported	-22.92	28.42	Not reported

Cycle 31 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	12
Crizotinib	2

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.8	Not reported	-11.84	27.51	Not reported
Crizotinib	0.0	Not reported	-190.59	190.59	Not reported

Cycle 32 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	10
Crizotinib	2

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	7.9	Not reported	-11.65	27.45	Not reported
Crizotinib	2.5	Not reported	-156.33	161.33	Not reported

Cycle 33 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	8
Crizotinib	2

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	4.4	Not reported	-21.74	30.49	Not reported
Crizotinib	-2.5	Not reported	-224.86	219.86	Not reported

Cycle 34 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	6
Crizotinib	1

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	-0.5	Not reported	-32.20	31.20	Not reported
Crizotinib	20.0	Not reported	Not reported	Not reported	Not reported

Cycle 35 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	4
Crizotinib	1

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.0	Not reported	-32.48	32.48	Not reported
Crizotinib	20.0	Not reported	Not reported	Not reported	Not reported

Cycle 36 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	2
Crizotinib	1

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	-4.5	Not reported	-315.80	306.80	Not reported
Crizotinib	15.0	Not reported	Not reported	Not reported	Not reported

Cycle 37 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	2
Crizotinib	0

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	-17.5	Not reported	-176.33	141.33	Not reported

Cycle 38 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	1
Crizotinib	0

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	25.0	Not reported	Not reported	Not reported	Not reported

End of Treatment

Analysis denominator · Participants

Group	Source count
Lorlatinib	27
Crizotinib	82

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	-3.7	Not reported	-13.66	6.33	Not reported
Crizotinib	-1.3	Not reported	-5.43	2.80	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
3.33
upper Limit
8.72
value
6.0
group Id
OG001
lower Limit
0.19
upper Limit
5.92
value
3.1
denoms
counts
group Id
OG000
value
143
group Id
OG001
value
133
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
lower Limit
3.30
upper Limit
8.75
value
6.0
group Id
OG001
lower Limit
2.37
upper Limit
8.18
value
5.3
denoms
counts
group Id
OG000
value
137
group Id
OG001
value
124
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
lower Limit
3.71
upper Limit
10.41
value
7.1
group Id
OG001
lower Limit
2.77
upper Limit
8.47
value
5.6
denoms
counts
group Id
OG000
value
133
group Id
OG001
value
122
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
lower Limit
0.39
upper Limit
8.13
value
4.3
group Id
OG001
lower Limit
1.88
upper Limit
8.26
value
5.1
denoms
counts
group Id
OG000
value
130
group Id
OG001
value
115
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
lower Limit
3.11
upper Limit
9.85
value
6.5
group Id
OG001
lower Limit
1.08
upper Limit
7.91
value
4.5
denoms
counts
group Id
OG000
value
127
group Id
OG001
value
105
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
lower Limit
1.95
upper Limit
9.13
value
5.5
group Id
OG001
lower Limit
0.35
upper Limit
7.55
value
4.0
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
100
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
lower Limit
2.95
upper Limit
10.37
value
6.7
group Id
OG001
lower Limit
0.63
upper Limit
7.68
value
4.2
denoms
counts
group Id
OG000
value
125
group Id
OG001
value
94
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
lower Limit
2.47
upper Limit
10.33
value
6.4
group Id
OG001
lower Limit
0.09
upper Limit
7.69
value
3.9
denoms
counts
group Id
OG000
value
120
group Id
OG001
value
82
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
lower Limit
3.22
upper Limit
11.20
value
7.2
group Id
OG001
lower Limit
-0.02
upper Limit
7.75
value
3.9
denoms
counts
group Id
OG000
value
116
group Id
OG001
value
74
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
lower Limit
4.27
upper Limit
11.83
value
8.1
group Id
OG001
lower Limit
-1.62
upper Limit
5.59
value
2.0
denoms
counts
group Id
OG000
value
117
group Id
OG001
value
73
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG000
lower Limit
3.82
upper Limit
11.41
value
7.6
group Id
OG001
lower Limit
0.95
upper Limit
8.59
value
4.8
denoms
counts
group Id
OG000
value
117
group Id
OG001
value
61
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
lower Limit
3.91
upper Limit
11.11
value
7.5
group Id
OG001
lower Limit
1.99
upper Limit
9.51
value
5.8
denoms
counts
group Id
OG000
value
114
group Id
OG001
value
56
units
Participants
title
Cycle 13 Day 1

denoms

counts
group Id
OG000
value
147
group Id
OG001
value
138
units
Participants

description

The EuroQol EQ-5D-5L is a participant-completed questionnaire designed to assess health status. There are 2 components to the EuroQol EQ-5D-5L: a descriptive system in which individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a VAS. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) and higher scores indicate better health state.

dispersion Type

95% Confidence Interval

groups

description
Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
id
OG000
title
Lorlatinib
description
Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
id
OG001
title
Crizotinib

param Type

MEAN

population Description

"Number of Participants Analyzed" included all participants in the EQ-5D-5L PRO analysis population within each treatment group. "Number Analyzed" included all participants with at least a baseline and postbaseline assessment at the visit.

reporting Status

POSTED

time Frame

Baseline, Day 1 of all cycles from Cycle 2 to Cycle 38, and End of Treatment

title

Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time

type

SECONDARY

unit Of Measure

Units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice