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NCT03052608 · OUTCOME

Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index 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 in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).

Analysis population: "Number of Participants Analyzed" included all participants in the 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	148
Crizotinib	140

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	141
Crizotinib	133

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.078	Not reported	0.0475	0.1092	Not reported
Crizotinib	0.064	Not reported	0.0258	0.1021	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	138
Crizotinib	124

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.071	Not reported	0.0327	0.1097	Not reported
Crizotinib	0.101	Not reported	0.0665	0.1353	Not reported

Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	131
Crizotinib	121

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.089	Not reported	0.0520	0.1254	Not reported
Crizotinib	0.098	Not reported	0.0619	0.1338	Not reported

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	130
Crizotinib	114

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.047	Not reported	0.0061	0.0887	Not reported
Crizotinib	0.100	Not reported	0.0626	0.1373	Not reported

Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	126
Crizotinib	104

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.077	Not reported	0.0407	0.1124	Not reported
Crizotinib	0.070	Not reported	0.0324	0.1077	Not reported

Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	121
Crizotinib	99

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.062	Not reported	0.0180	0.1052	Not reported
Crizotinib	0.046	Not reported	0.0002	0.0910	Not reported

Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	124
Crizotinib	93

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.074	Not reported	0.0340	0.1133	Not reported
Crizotinib	0.061	Not reported	0.0201	0.1011	Not reported

Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	118
Crizotinib	82

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.060	Not reported	0.0175	0.1028	Not reported
Crizotinib	0.050	Not reported	0.0082	0.0919	Not reported

Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	115
Crizotinib	75

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.074	Not reported	0.0303	0.1179	Not reported
Crizotinib	0.050	Not reported	0.0168	0.0826	Not reported

Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	116
Crizotinib	73

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.083	Not reported	0.0418	0.1237	Not reported
Crizotinib	0.057	Not reported	0.0222	0.0914	Not reported

Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	116
Crizotinib	61

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.080	Not reported	0.0390	0.1201	Not reported
Crizotinib	0.049	Not reported	0.0118	0.0864	Not reported

Cycle 13 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	113
Crizotinib	56

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.081	Not reported	0.0365	0.1259	Not reported
Crizotinib	0.055	Not reported	0.0165	0.0931	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	0.091	Not reported	0.0490	0.1322	Not reported
Crizotinib	0.021	Not reported	-0.0157	0.0576	Not reported

Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	110
Crizotinib	43

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.077	Not reported	0.0314	0.1217	Not reported
Crizotinib	0.036	Not reported	-0.0100	0.0811	Not reported

Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	103
Crizotinib	39

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.091	Not reported	0.0469	0.1347	Not reported
Crizotinib	0.051	Not reported	0.0070	0.0953	Not reported

Cycle 17 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	91
Crizotinib	31

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.098	Not reported	0.0523	0.1434	Not reported
Crizotinib	-0.016	Not reported	-0.1000	0.0685	Not reported

Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	84
Crizotinib	28

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.103	Not reported	0.0520	0.1531	Not reported
Crizotinib	0.021	Not reported	-0.0296	0.0716	Not reported

Cycle 19 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	79
Crizotinib	21

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.100	Not reported	0.0481	0.1518	Not reported
Crizotinib	0.027	Not reported	-0.0246	0.0793	Not reported

Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Lorlatinib	69
Crizotinib	18

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	0.103	Not reported	0.0459	0.1596	Not reported
Crizotinib	0.025	Not reported	-0.0593	0.1090	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	0.068	Not reported	0.0091	0.1276	Not reported
Crizotinib	0.040	Not reported	-0.0187	0.0989	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	0.079	Not reported	0.0134	0.1447	Not reported
Crizotinib	0.052	Not reported	-0.0249	0.1289	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	0.060	Not reported	-0.0127	0.1324	Not reported
Crizotinib	0.006	Not reported	-0.2020	0.2133	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	0.082	Not reported	0.0104	0.1531	Not reported
Crizotinib	-0.053	Not reported	-0.2793	0.1731	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	0.047	Not reported	-0.0287	0.1231	Not reported
Crizotinib	0.045	Not reported	-0.0289	0.1194	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	0.065	Not reported	-0.0218	0.1519	Not reported
Crizotinib	0.039	Not reported	-0.0200	0.0978	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	0.042	Not reported	-0.0603	0.1434	Not reported
Crizotinib	0.021	Not reported	-0.0867	0.1292	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	0.024	Not reported	-0.0911	0.1399	Not reported
Crizotinib	-0.040	Not reported	-0.1640	0.0836	Not reported

Cycle 29 Day 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	0.046	Not reported	-0.0836	0.1755	Not reported
Crizotinib	0.041	Not reported	-0.0108	0.0928	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	0.099	Not reported	-0.0355	0.2306	Not reported
Crizotinib	-0.028	Not reported	-0.1740	0.1190	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	0.086	Not reported	-0.0957	0.2683	Not reported
Crizotinib	-0.024	Not reported	-0.8558	0.8088	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	0.058	Not reported	-0.1601	0.2767	Not reported
Crizotinib	-0.139	Not reported	-2.4320	2.1550	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	0.058	Not reported	-0.2006	0.3163	Not reported
Crizotinib	-0.024	Not reported	-0.8558	0.8088	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	0.062	Not reported	-0.2820	0.4057	Not reported
Crizotinib	0.042	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	0.129	Not reported	-0.1098	0.3668	Not reported
Crizotinib	0.042	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	-0.027	Not reported	-1.7736	1.7206	Not reported
Crizotinib	0.042	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	0.056	Not reported	-0.6497	0.7607	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	0.232	Not reported	Not reported	Not reported	Not reported

End of Treatment

Analysis denominator · Participants

Group	Source count
Lorlatinib	27
Crizotinib	79

Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lorlatinib	-0.033	Not reported	-0.1513	0.0852	Not reported
Crizotinib	0.001	Not reported	-0.0769	0.0782	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.0475
upper Limit
0.1092
value
0.078
group Id
OG001
lower Limit
0.0258
upper Limit
0.1021
value
0.064
denoms
counts
group Id
OG000
value
141
group Id
OG001
value
133
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0327
upper Limit
0.1097
value
0.071
group Id
OG001
lower Limit
0.0665
upper Limit
0.1353
value
0.101
denoms
counts
group Id
OG000
value
138
group Id
OG001
value
124
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0520
upper Limit
0.1254
value
0.089
group Id
OG001
lower Limit
0.0619
upper Limit
0.1338
value
0.098
denoms
counts
group Id
OG000
value
131
group Id
OG001
value
121
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0061
upper Limit
0.0887
value
0.047
group Id
OG001
lower Limit
0.0626
upper Limit
0.1373
value
0.100
denoms
counts
group Id
OG000
value
130
group Id
OG001
value
114
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0407
upper Limit
0.1124
value
0.077
group Id
OG001
lower Limit
0.0324
upper Limit
0.1077
value
0.070
denoms
counts
group Id
OG000
value
126
group Id
OG001
value
104
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0180
upper Limit
0.1052
value
0.062
group Id
OG001
lower Limit
0.0002
upper Limit
0.0910
value
0.046
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
99
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0340
upper Limit
0.1133
value
0.074
group Id
OG001
lower Limit
0.0201
upper Limit
0.1011
value
0.061
denoms
counts
group Id
OG000
value
124
group Id
OG001
value
93
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0175
upper Limit
0.1028
value
0.060
group Id
OG001
lower Limit
0.0082
upper Limit
0.0919
value
0.050
denoms
counts
group Id
OG000
value
118
group Id
OG001
value
82
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0303
upper Limit
0.1179
value
0.074
group Id
OG001
lower Limit
0.0168
upper Limit
0.0826
value
0.050
denoms
counts
group Id
OG000
value
115
group Id
OG001
value
75
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0418
upper Limit
0.1237
value
0.083
group Id
OG001
lower Limit
0.0222
upper Limit
0.0914
value
0.057
denoms
counts
group Id
OG000
value
116
group Id
OG001
value
73
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0390
upper Limit
0.1201
value
0.080
group Id
OG001
lower Limit
0.0118
upper Limit
0.0864
value
0.049
denoms
counts
group Id
OG000
value
116
group Id
OG001
value
61
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
lower Limit
0.0365
upper Limit
0.1259
value
0.081
group Id
OG001
lower Limit
0.0165
upper Limit
0.0931
value
0.055
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
56
units
Participants
title
Cycle 13 Day 1

denoms

counts
group Id
OG000
value
148
group Id
OG001
value
140
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 in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).

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 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) - Index 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