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NCT03088540 · OUTCOME

Change From Baseline in Global Health Status/Quality of Life (QoL) Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-06-25

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

Measure: MEAN
Unit: score on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39

What was measured

The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (physical, role, cognitive, emotional, social), 9 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a score ranging from 0 to 100; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.

Analysis population: FAS included all randomized participants. Overall number of participants analysed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint.

Groups in this outcome

Cemiplimab

Participants received cemiplimab monotherapy

Chemotherapy

Participants received platinum-based doublet chemotherapy

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
Cemiplimab	357
Chemotherapy	355

Reported measurements

Cycle 2, Day 1 (C2D1)

Analysis denominator · Participants

Group	Source count
Cemiplimab	332
Chemotherapy	316

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	4.92	20.455	Not reported	Not reported	Not reported
Chemotherapy	0.45	19.291	Not reported	Not reported	Not reported

C3D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	310
Chemotherapy	300

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	7.23	21.928	Not reported	Not reported	Not reported
Chemotherapy	1.25	21.019	Not reported	Not reported	Not reported

C4D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	286
Chemotherapy	257

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	8.13	21.925	Not reported	Not reported	Not reported
Chemotherapy	2.43	21.795	Not reported	Not reported	Not reported

C5D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	266
Chemotherapy	213

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	8.27	24.422	Not reported	Not reported	Not reported
Chemotherapy	1.88	21.803	Not reported	Not reported	Not reported

C6D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	255
Chemotherapy	189

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	9.64	22.910	Not reported	Not reported	Not reported
Chemotherapy	3.00	20.909	Not reported	Not reported	Not reported

C9D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	216
Chemotherapy	49

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	10.19	23.359	Not reported	Not reported	Not reported
Chemotherapy	2.55	20.142	Not reported	Not reported	Not reported

C12D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	174
Chemotherapy	30

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	11.11	23.077	Not reported	Not reported	Not reported
Chemotherapy	-4.17	19.543	Not reported	Not reported	Not reported

C15D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	147
Chemotherapy	14

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	10.88	24.705	Not reported	Not reported	Not reported
Chemotherapy	5.36	19228	Not reported	Not reported	Not reported

C18D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	132
Chemotherapy	11

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	10.10	26.792	Not reported	Not reported	Not reported
Chemotherapy	-3.03	22.753	Not reported	Not reported	Not reported

C21D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	113
Chemotherapy	7

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	13.42	25.060	Not reported	Not reported	Not reported
Chemotherapy	-1.19	11.210	Not reported	Not reported	Not reported

C24D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	103
Chemotherapy	7

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	10.76	22.676	Not reported	Not reported	Not reported
Chemotherapy	1.19	12.199	Not reported	Not reported	Not reported

C27D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	92
Chemotherapy	5

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	12.50	24.225	Not reported	Not reported	Not reported
Chemotherapy	-3.33	12.638	Not reported	Not reported	Not reported

C30D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	88
Chemotherapy	4

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	11.74	24.358	Not reported	Not reported	Not reported
Chemotherapy	-4.17	10.758	Not reported	Not reported	Not reported

C33D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	78
Chemotherapy	4

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	9.62	26.355	Not reported	Not reported	Not reported
Chemotherapy	0.00	11.785	Not reported	Not reported	Not reported

C36D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	72
Chemotherapy	2

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	11.69	24.928	Not reported	Not reported	Not reported
Chemotherapy	4.17	5.893	Not reported	Not reported	Not reported

C39D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	0
Chemotherapy	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy	8.33	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
20.455
value
4.92
group Id
OG001
spread
19.291
value
0.45
denoms
counts
group Id
OG000
value
332
group Id
OG001
value
316
units
Participants
title
Cycle 2, Day 1 (C2D1)
categories
measurements
group Id
OG000
spread
21.928
value
7.23
group Id
OG001
spread
21.019
value
1.25
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
300
units
Participants
title
C3D1
categories
measurements
group Id
OG000
spread
21.925
value
8.13
group Id
OG001
spread
21.795
value
2.43
denoms
counts
group Id
OG000
value
286
group Id
OG001
value
257
units
Participants
title
C4D1
categories
measurements
group Id
OG000
spread
24.422
value
8.27
group Id
OG001
spread
21.803
value
1.88
denoms
counts
group Id
OG000
value
266
group Id
OG001
value
213
units
Participants
title
C5D1
categories
measurements
group Id
OG000
spread
22.910
value
9.64
group Id
OG001
spread
20.909
value
3.00
denoms
counts
group Id
OG000
value
255
group Id
OG001
value
189
units
Participants
title
C6D1
categories
measurements
group Id
OG000
spread
23.359
value
10.19
group Id
OG001
spread
20.142
value
2.55
denoms
counts
group Id
OG000
value
216
group Id
OG001
value
49
units
Participants
title
C9D1
categories
measurements
group Id
OG000
spread
23.077
value
11.11
group Id
OG001
spread
19.543
value
-4.17
denoms
counts
group Id
OG000
value
174
group Id
OG001
value
30
units
Participants
title
C12D1
categories
measurements
group Id
OG000
spread
24.705
value
10.88
group Id
OG001
spread
19228
value
5.36
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
14
units
Participants
title
C15D1
categories
measurements
group Id
OG000
spread
26.792
value
10.10
group Id
OG001
spread
22.753
value
-3.03
denoms
counts
group Id
OG000
value
132
group Id
OG001
value
11
units
Participants
title
C18D1
categories
measurements
group Id
OG000
spread
25.060
value
13.42
group Id
OG001
spread
11.210
value
-1.19
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
7
units
Participants
title
C21D1
categories
measurements
group Id
OG000
spread
22.676
value
10.76
group Id
OG001
spread
12.199
value
1.19
denoms
counts
group Id
OG000
value
103
group Id
OG001
value
7
units
Participants
title
C24D1
categories
measurements
group Id
OG000
spread
24.225
value
12.50
group Id
OG001
spread
12.638
value
-3.33
denoms
counts
group Id
OG000
value
92
group Id
OG001
value
5
units
Participants
title
C27D1

denoms

counts
group Id
OG000
value
357
group Id
OG001
value
355
units
Participants

description

The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (physical, role, cognitive, emotional, social), 9 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a score ranging from 0 to 100; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.

dispersion Type

Standard Deviation

groups

description
Participants received cemiplimab monotherapy
id
OG000
title
Cemiplimab
description
Participants received platinum-based doublet chemotherapy
id
OG001
title
Chemotherapy

param Type

MEAN

population Description

FAS included all randomized participants. Overall number of participants analysed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint.

reporting Status

POSTED

time Frame

Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39

title

Change From Baseline in Global Health Status/Quality of Life (QoL) Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

type

SECONDARY

unit Of Measure

score on a scale

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

Preserved source evidence · Not medical advice