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NCT03409614 · OUTCOME

Part 2: Change From Baseline in Global Health Status Score as Measured by the EORTC QLQ-C30

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer · Source last updated 2026-05-18

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; Follow-up 1 (14 to 30 days after last study treatment)

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 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.

Analysis population: Includes only participants in part 2 with both baseline and at least one post-baseline value. Overall number of participants analysed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint

Groups in this outcome

Part 2: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

Part 2: Placebo + Chemotherapy

Placebo matching cemiplimab plus 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
Part 2: Cemiplimab + Chemotherapy	297
Part 2: Placebo + Chemotherapy	144

Reported measurements

C2D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	296
Part 2: Placebo + Chemotherapy	144

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	0.31	17.199	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	1.50	18.190	Not reported	Not reported	Not reported

C3D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	277
Part 2: Placebo + Chemotherapy	134

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	0.96	17.175	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	2.80	17.098	Not reported	Not reported	Not reported

C4D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	265
Part 2: Placebo + Chemotherapy	114

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	1.92	19.293	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	4.09	18.592	Not reported	Not reported	Not reported

C5D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	254
Part 2: Placebo + Chemotherapy	106

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	3.35	18.912	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	2.28	21.686	Not reported	Not reported	Not reported

C6D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	244
Part 2: Placebo + Chemotherapy	101

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	3.42	19.649	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	2.89	19.452	Not reported	Not reported	Not reported

C9D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	203
Part 2: Placebo + Chemotherapy	66

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	3.65	19.657	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	2.02	21.236	Not reported	Not reported	Not reported

C12D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	165
Part 2: Placebo + Chemotherapy	40

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	2.37	19.056	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	3.54	23.862	Not reported	Not reported	Not reported

C15D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	135
Part 2: Placebo + Chemotherapy	29

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	6.23	18.090	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	6.61	22.091	Not reported	Not reported	Not reported

C18D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	120
Part 2: Placebo + Chemotherapy	19

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	5.28	21.578	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	10.09	22.323	Not reported	Not reported	Not reported

C21D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	107
Part 2: Placebo + Chemotherapy	13

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	6.07	21.340	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	18.59	22.088	Not reported	Not reported	Not reported

C24D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	94
Part 2: Placebo + Chemotherapy	10

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	5.05	20.347	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	10.83	25.474	Not reported	Not reported	Not reported

C27D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	87
Part 2: Placebo + Chemotherapy	9

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	5.27	21.905	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	8.33	27.003	Not reported	Not reported	Not reported

C30D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	77
Part 2: Placebo + Chemotherapy	4

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	6.82	19.947	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	4.17	45.896	Not reported	Not reported	Not reported

C33D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	75
Part 2: Placebo + Chemotherapy	3

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	4.56	20.518	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	27.78	25.459	Not reported	Not reported	Not reported

C36D1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	66
Part 2: Placebo + Chemotherapy	2

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	6.94	21.363	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	41.67	11.785	Not reported	Not reported	Not reported

Follow-up 1

Analysis denominator · Participants

Group	Source count
Part 2: Cemiplimab + Chemotherapy	148
Part 2: Placebo + Chemotherapy	59

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Cemiplimab + Chemotherapy	-2.70	21.826	Not reported	Not reported	Not reported
Part 2: Placebo + Chemotherapy	-0.99	23.422	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
17.199
value
0.31
group Id
OG001
spread
18.190
value
1.50
denoms
counts
group Id
OG000
value
296
group Id
OG001
value
144
units
Participants
title
C2D1
categories
measurements
group Id
OG000
spread
17.175
value
0.96
group Id
OG001
spread
17.098
value
2.80
denoms
counts
group Id
OG000
value
277
group Id
OG001
value
134
units
Participants
title
C3D1
categories
measurements
group Id
OG000
spread
19.293
value
1.92
group Id
OG001
spread
18.592
value
4.09
denoms
counts
group Id
OG000
value
265
group Id
OG001
value
114
units
Participants
title
C4D1
categories
measurements
group Id
OG000
spread
18.912
value
3.35
group Id
OG001
spread
21.686
value
2.28
denoms
counts
group Id
OG000
value
254
group Id
OG001
value
106
units
Participants
title
C5D1
categories
measurements
group Id
OG000
spread
19.649
value
3.42
group Id
OG001
spread
19.452
value
2.89
denoms
counts
group Id
OG000
value
244
group Id
OG001
value
101
units
Participants
title
C6D1
categories
measurements
group Id
OG000
spread
19.657
value
3.65
group Id
OG001
spread
21.236
value
2.02
denoms
counts
group Id
OG000
value
203
group Id
OG001
value
66
units
Participants
title
C9D1
categories
measurements
group Id
OG000
spread
19.056
value
2.37
group Id
OG001
spread
23.862
value
3.54
denoms
counts
group Id
OG000
value
165
group Id
OG001
value
40
units
Participants
title
C12D1
categories
measurements
group Id
OG000
spread
18.090
value
6.23
group Id
OG001
spread
22.091
value
6.61
denoms
counts
group Id
OG000
value
135
group Id
OG001
value
29
units
Participants
title
C15D1
categories
measurements
group Id
OG000
spread
21.578
value
5.28
group Id
OG001
spread
22.323
value
10.09
denoms
counts
group Id
OG000
value
120
group Id
OG001
value
19
units
Participants
title
C18D1
categories
measurements
group Id
OG000
spread
21.340
value
6.07
group Id
OG001
spread
22.088
value
18.59
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
13
units
Participants
title
C21D1
categories
measurements
group Id
OG000
spread
20.347
value
5.05
group Id
OG001
spread
25.474
value
10.83
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
10
units
Participants
title
C24D1
categories
measurements
group Id
OG000
spread
21.905
value
5.27
group Id
OG001
spread
27.003
value
8.33
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
9
units
Participants
title
C27D1

denoms

counts
group Id
OG000
value
297
group Id
OG001
value
144
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 0-100 scale; 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 plus platinum-based doublet chemotherapy
id
OG000
title
Part 2: Cemiplimab + Chemotherapy
description
Placebo matching cemiplimab plus platinum-based doublet chemotherapy
id
OG001
title
Part 2: Placebo + Chemotherapy

param Type

MEAN

population Description

Includes only participants in part 2 with both baseline and at least one post-baseline value. 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; Follow-up 1 (14 to 30 days after last study treatment)

title

Part 2: Change From Baseline in Global Health Status Score as Measured by the 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