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NCT03088540 · OUTCOME

Change From Baseline in Coughing Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)

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

EORTC QLQ-LC13 is a 13-item questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia). Reported here are the EORTC lung cancer coughing scores only. Scores were calculated and transformed to a range from 0 to 100, with a higher score representing a higher level of symptoms/problems and a negative change from baseline value indicating reduction (i.e. improvement) in symptoms.

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	-4.12	25.777	Not reported	Not reported	Not reported
Chemotherapy	-4.32	26.406	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	-8.60	29.824	Not reported	Not reported	Not reported
Chemotherapy	-8.56	29.059	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	-11.19	28.598	Not reported	Not reported	Not reported
Chemotherapy	-11.41	30.181	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	-12.41	31.065	Not reported	Not reported	Not reported
Chemotherapy	-9.86	31.752	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	-13.33	30.251	Not reported	Not reported	Not reported
Chemotherapy	-11.11	28.142	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	-13.12	29.601	Not reported	Not reported	Not reported
Chemotherapy	-12.24	31.691	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	-13.22	28.179	Not reported	Not reported	Not reported
Chemotherapy	-5.56	30.429	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	-15.65	27.116	Not reported	Not reported	Not reported
Chemotherapy	-19.05	31.254	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	-16.16	27.777	Not reported	Not reported	Not reported
Chemotherapy	-15.15	27.340	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	-17.70	28.546	Not reported	Not reported	Not reported
Chemotherapy	-19.05	26.227	Not reported	Not reported	Not reported

C24D1

Analysis denominator · Participants

Group	Source count
Cemiplimab	102
Chemotherapy	7

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cemiplimab	-18.30	28.773	Not reported	Not reported	Not reported
Chemotherapy	-28.57	23.002	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	-17.75	34.041	Not reported	Not reported	Not reported
Chemotherapy	-26.67	27.889	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	-18.94	31.882	Not reported	Not reported	Not reported
Chemotherapy	-16.67	33.333	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	-18.38	30.222	Not reported	Not reported	Not reported
Chemotherapy	-8.33	41.944	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	-22.22	28.527	Not reported	Not reported	Not reported
Chemotherapy	-16.67	23.570	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	0.00	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
25.777
value
-4.12
group Id
OG001
spread
26.406
value
-4.32
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
29.824
value
-8.60
group Id
OG001
spread
29.059
value
-8.56
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
300
units
Participants
title
C3D1
categories
measurements
group Id
OG000
spread
28.598
value
-11.19
group Id
OG001
spread
30.181
value
-11.41
denoms
counts
group Id
OG000
value
286
group Id
OG001
value
257
units
Participants
title
C4D1
categories
measurements
group Id
OG000
spread
31.065
value
-12.41
group Id
OG001
spread
31.752
value
-9.86
denoms
counts
group Id
OG000
value
266
group Id
OG001
value
213
units
Participants
title
C5D1
categories
measurements
group Id
OG000
spread
30.251
value
-13.33
group Id
OG001
spread
28.142
value
-11.11
denoms
counts
group Id
OG000
value
255
group Id
OG001
value
189
units
Participants
title
C6D1
categories
measurements
group Id
OG000
spread
29.601
value
-13.12
group Id
OG001
spread
31.691
value
-12.24
denoms
counts
group Id
OG000
value
216
group Id
OG001
value
49
units
Participants
title
C9D1
categories
measurements
group Id
OG000
spread
28.179
value
-13.22
group Id
OG001
spread
30.429
value
-5.56
denoms
counts
group Id
OG000
value
174
group Id
OG001
value
30
units
Participants
title
C12D1
categories
measurements
group Id
OG000
spread
27.116
value
-15.65
group Id
OG001
spread
31.254
value
-19.05
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
14
units
Participants
title
C15D1
categories
measurements
group Id
OG000
spread
27.777
value
-16.16
group Id
OG001
spread
27.340
value
-15.15
denoms
counts
group Id
OG000
value
132
group Id
OG001
value
11
units
Participants
title
C18D1
categories
measurements
group Id
OG000
spread
28.546
value
-17.70
group Id
OG001
spread
26.227
value
-19.05
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
7
units
Participants
title
C21D1
categories
measurements
group Id
OG000
spread
28.773
value
-18.30
group Id
OG001
spread
23.002
value
-28.57
denoms
counts
group Id
OG000
value
102
group Id
OG001
value
7
units
Participants
title
C24D1
categories
measurements
group Id
OG000
spread
34.041
value
-17.75
group Id
OG001
spread
27.889
value
-26.67
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

EORTC QLQ-LC13 is a 13-item questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia). Reported here are the EORTC lung cancer coughing scores only. Scores were calculated and transformed to a range from 0 to 100, with a higher score representing a higher level of symptoms/problems and a negative change from baseline value indicating reduction (i.e. improvement) in symptoms.

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 Coughing Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)

type

SECONDARY

unit Of Measure

score on a scale

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

Preserved source evidence · Not medical advice