NCT00981058 · OUTCOME

Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin · Source last updated 2025-06-18

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

Measure: MEAN
Unit: millimeter (mm)
Interval / dispersion: Standard Deviation
Time frame: Baseline, Cycle 6 (Cycle = 3 Weeks)

What was measured

The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.

Analysis population: All randomized participants who had evaluable data for LCSS.

Groups in this outcome

Necitumumab + Gemcitabine + Cisplatin

Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.

Gemcitabine + Cisplatin

Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.

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
Necitumumab + Gemcitabine + Cisplatin	545
Gemcitabine + Cisplatin	548

Reported measurements

Loss of Appetite (n=304, 242)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	1.8	31.84	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	1.5	29.30	Not reported	Not reported	Not reported

Fatigue (n=302, 242)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	6.3	29.15	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	3.5	25.29	Not reported	Not reported	Not reported

Cough (n=303, 243)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-7.8	28.05	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-9.1	25.74	Not reported	Not reported	Not reported

Dyspnea (n=305, 244)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-2.8	26.52	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-1.8	25.27	Not reported	Not reported	Not reported

Pain (n=302, 243)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-3.3	17.98	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-2.2	17.22	Not reported	Not reported	Not reported

Overall Symptoms (n=303, 242)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-0.3	26.19	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-0.6	26.92	Not reported	Not reported	Not reported

Interference (n=306,241)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	3.8	29.74	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	2.2	26.79	Not reported	Not reported	Not reported

Quality of Life (n=305, 243)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-0.3	27.35	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-1.6	24.71	Not reported	Not reported	Not reported

Average Symptom Burden Index (ASBI) (n=294, 234)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-1.9	16.55	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-1.5	16.52	Not reported	Not reported	Not reported

LCSS Total Score (n=290, 228)

Values in millimeter (mm) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	-0.8	17.03	Not reported	Not reported	Not reported
Gemcitabine + Cisplatin	-0.8	16.17	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
31.84
value
1.8
group Id
OG001
spread
29.30
value
1.5
title
Loss of Appetite (n=304, 242)
categories
measurements
group Id
OG000
spread
29.15
value
6.3
group Id
OG001
spread
25.29
value
3.5
title
Fatigue (n=302, 242)
categories
measurements
group Id
OG000
spread
28.05
value
-7.8
group Id
OG001
spread
25.74
value
-9.1
title
Cough (n=303, 243)
categories
measurements
group Id
OG000
spread
26.52
value
-2.8
group Id
OG001
spread
25.27
value
-1.8
title
Dyspnea (n=305, 244)
categories
measurements
group Id
OG000
spread
17.98
value
-3.3
group Id
OG001
spread
17.22
value
-2.2
title
Pain (n=302, 243)
categories
measurements
group Id
OG000
spread
26.19
value
-0.3
group Id
OG001
spread
26.92
value
-0.6
title
Overall Symptoms (n=303, 242)
categories
measurements
group Id
OG000
spread
29.74
value
3.8
group Id
OG001
spread
26.79
value
2.2
title
Interference (n=306,241)
categories
measurements
group Id
OG000
spread
27.35
value
-0.3
group Id
OG001
spread
24.71
value
-1.6
title
Quality of Life (n=305, 243)
categories
measurements
group Id
OG000
spread
16.55
value
-1.9
group Id
OG001
spread
16.52
value
-1.5
title
Average Symptom Burden Index (ASBI) (n=294, 234)
categories
measurements
group Id
OG000
spread
17.03
value
-0.8
group Id
OG001
spread
16.17
value
-0.8
title
LCSS Total Score (n=290, 228)

denoms

counts
group Id
OG000
value
545
group Id
OG001
value
548
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
id
OG000
title
Necitumumab + Gemcitabine + Cisplatin
description
Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
id
OG001
title
Gemcitabine + Cisplatin

param Type

MEAN

population Description

All randomized participants who had evaluable data for LCSS.

reporting Status

POSTED

time Frame

Baseline, Cycle 6 (Cycle = 3 Weeks)

title

Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)

type

SECONDARY

unit Of Measure

millimeter (mm)

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Preserved source evidence · Not medical advice