Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). · Source last updated 2026-03-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever came first). Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).
What was measured
The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
Analysis population: Global cohort: The FAS included all randomized patients. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.
Groups in this outcome
T + D + SoC
During chemotherapy (combination) stage:
Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
D + SoC
During chemotherapy (combination) stage:
Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
SoC Alone
During chemotherapy (combination) stage:
Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.
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
T + D + SoC
325
D + SoC
326
SoC Alone
321
Reported measurements
QLQ-C30 Global Health Status / HRQoL
Analysis denominator · Participants
Group
Source count
T + D + SoC
319
D + SoC
321
SoC Alone
318
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
8.3
Not reported
6.4
10.2
Not reported
D + SoC
7.8
Not reported
6.5
9.5
Not reported
SoC Alone
5.6
Not reported
4.4
7.5
Not reported
QLQ-C30 Physical Functioning
Analysis denominator · Participants
Group
Source count
T + D + SoC
323
D + SoC
325
SoC Alone
320
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
7.7
Not reported
5.9
9.4
Not reported
D + SoC
8.3
Not reported
6.6
10.0
Not reported
SoC Alone
5.3
Not reported
4.2
6.5
Not reported
QLQ-C30 Role Functioning
Analysis denominator · Participants
Group
Source count
T + D + SoC
314
D + SoC
313
SoC Alone
304
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
6.6
Not reported
5.4
8.3
Not reported
D + SoC
7.4
Not reported
5.8
9.3
Not reported
SoC Alone
4.8
Not reported
3.6
6.2
Not reported
QLQ-C30 Cognitive Functioning
Analysis denominator · Participants
Group
Source count
T + D + SoC
323
D + SoC
323
SoC Alone
318
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
7.6
Not reported
6.1
9.7
Not reported
D + SoC
7.4
Not reported
5.6
9.3
Not reported
SoC Alone
5.8
Not reported
4.6
7.5
Not reported
QLQ-C30 Emotional Functioning
Analysis denominator · Participants
Group
Source count
T + D + SoC
322
D + SoC
322
SoC Alone
315
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
8.5
Not reported
6.6
11.3
Not reported
D + SoC
9.5
Not reported
7.4
12.0
Not reported
SoC Alone
7.5
Not reported
5.8
11.0
Not reported
QLQ-C30 Social Functioning
Analysis denominator · Participants
Group
Source count
T + D + SoC
320
D + SoC
319
SoC Alone
314
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
6.4
Not reported
5.6
9.4
Not reported
D + SoC
7.1
Not reported
5.0
9.6
Not reported
SoC Alone
5.7
Not reported
4.6
7.4
Not reported
QLQ-C30 Fatigue
Analysis denominator · Participants
Group
Source count
T + D + SoC
317
D + SoC
318
SoC Alone
314
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
3.7
Not reported
2.8
5.0
Not reported
D + SoC
3.8
Not reported
2.9
4.9
Not reported
SoC Alone
2.8
Not reported
2.1
3.7
Not reported
QLQ-C30 Pain
Analysis denominator · Participants
Group
Source count
T + D + SoC
316
D + SoC
311
SoC Alone
298
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
8.9
Not reported
6.2
10.9
Not reported
D + SoC
6.5
Not reported
5.6
8.6
Not reported
SoC Alone
5.7
Not reported
4.6
7.2
Not reported
QLQ-C30 Nausea / Vomiting
Analysis denominator · Participants
Group
Source count
T + D + SoC
322
D + SoC
322
SoC Alone
319
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
7.8
Not reported
5.6
10.0
Not reported
D + SoC
5.6
Not reported
4.1
6.6
Not reported
SoC Alone
5.6
Not reported
4.2
7.5
Not reported
QLQ-C30 Dyspnea
Analysis denominator · Participants
Group
Source count
T + D + SoC
310
D + SoC
310
SoC Alone
301
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
7.9
Not reported
5.8
9.8
Not reported
D + SoC
6.9
Not reported
5.8
8.9
Not reported
SoC Alone
6.7
Not reported
5.5
8.8
Not reported
QLQ-C30 Insomnia
Analysis denominator · Participants
Group
Source count
T + D + SoC
311
D + SoC
304
SoC Alone
301
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
8.3
Not reported
6.4
10.4
Not reported
D + SoC
7.4
Not reported
5.6
9.8
Not reported
SoC Alone
5.8
Not reported
4.2
7.2
Not reported
QLQ-C30 Appetite Loss
Analysis denominator · Participants
Group
Source count
T + D + SoC
308
D + SoC
316
SoC Alone
305
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
7.2
Not reported
5.7
9.4
Not reported
D + SoC
7.2
Not reported
4.7
8.8
Not reported
SoC Alone
7.0
Not reported
5.6
9.6
Not reported
QLQ-C30 Constipation
Analysis denominator · Participants
Group
Source count
T + D + SoC
315
D + SoC
314
SoC Alone
306
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
9.2
Not reported
6.4
12.2
Not reported
D + SoC
8.7
Not reported
6.5
10.0
Not reported
SoC Alone
6.1
Not reported
4.8
7.5
Not reported
QLQ-C30 Diarrhea
Analysis denominator · Participants
Group
Source count
T + D + SoC
324
D + SoC
324
SoC Alone
320
Values in months · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
T + D + SoC
11.0
Not reported
9.3
13.6
Not reported
D + SoC
9.8
Not reported
8.1
12.9
Not reported
SoC Alone
10.8
Not reported
9.2
15.1
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
6.4
upper Limit
10.2
value
8.3
group Id
OG001
lower Limit
6.5
upper Limit
9.5
value
7.8
group Id
OG002
lower Limit
4.4
upper Limit
7.5
value
5.6
denoms
counts
group Id
OG000
value
319
group Id
OG001
value
321
group Id
OG002
value
318
units
Participants
title
QLQ-C30 Global Health Status / HRQoL
categories
measurements
group Id
OG000
lower Limit
5.9
upper Limit
9.4
value
7.7
group Id
OG001
lower Limit
6.6
upper Limit
10.0
value
8.3
group Id
OG002
lower Limit
4.2
upper Limit
6.5
value
5.3
denoms
counts
group Id
OG000
value
323
group Id
OG001
value
325
group Id
OG002
value
320
units
Participants
title
QLQ-C30 Physical Functioning
categories
measurements
group Id
OG000
lower Limit
5.4
upper Limit
8.3
value
6.6
group Id
OG001
lower Limit
5.8
upper Limit
9.3
value
7.4
group Id
OG002
lower Limit
3.6
upper Limit
6.2
value
4.8
denoms
counts
group Id
OG000
value
314
group Id
OG001
value
313
group Id
OG002
value
304
units
Participants
title
QLQ-C30 Role Functioning
categories
measurements
group Id
OG000
lower Limit
6.1
upper Limit
9.7
value
7.6
group Id
OG001
lower Limit
5.6
upper Limit
9.3
value
7.4
group Id
OG002
lower Limit
4.6
upper Limit
7.5
value
5.8
denoms
counts
group Id
OG000
value
323
group Id
OG001
value
323
group Id
OG002
value
318
units
Participants
title
QLQ-C30 Cognitive Functioning
categories
measurements
group Id
OG000
lower Limit
6.6
upper Limit
11.3
value
8.5
group Id
OG001
lower Limit
7.4
upper Limit
12.0
value
9.5
group Id
OG002
lower Limit
5.8
upper Limit
11.0
value
7.5
denoms
counts
group Id
OG000
value
322
group Id
OG001
value
322
group Id
OG002
value
315
units
Participants
title
QLQ-C30 Emotional Functioning
categories
measurements
group Id
OG000
lower Limit
5.6
upper Limit
9.4
value
6.4
group Id
OG001
lower Limit
5.0
upper Limit
9.6
value
7.1
group Id
OG002
lower Limit
4.6
upper Limit
7.4
value
5.7
denoms
counts
group Id
OG000
value
320
group Id
OG001
value
319
group Id
OG002
value
314
units
Participants
title
QLQ-C30 Social Functioning
categories
measurements
group Id
OG000
lower Limit
2.8
upper Limit
5.0
value
3.7
group Id
OG001
lower Limit
2.9
upper Limit
4.9
value
3.8
group Id
OG002
lower Limit
2.1
upper Limit
3.7
value
2.8
denoms
counts
group Id
OG000
value
317
group Id
OG001
value
318
group Id
OG002
value
314
units
Participants
title
QLQ-C30 Fatigue
categories
measurements
group Id
OG000
lower Limit
6.2
upper Limit
10.9
value
8.9
group Id
OG001
lower Limit
5.6
upper Limit
8.6
value
6.5
group Id
OG002
lower Limit
4.6
upper Limit
7.2
value
5.7
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
311
group Id
OG002
value
298
units
Participants
title
QLQ-C30 Pain
categories
measurements
group Id
OG000
lower Limit
5.6
upper Limit
10.0
value
7.8
group Id
OG001
lower Limit
4.1
upper Limit
6.6
value
5.6
group Id
OG002
lower Limit
4.2
upper Limit
7.5
value
5.6
denoms
counts
group Id
OG000
value
322
group Id
OG001
value
322
group Id
OG002
value
319
units
Participants
title
QLQ-C30 Nausea / Vomiting
categories
measurements
group Id
OG000
lower Limit
5.8
upper Limit
9.8
value
7.9
group Id
OG001
lower Limit
5.8
upper Limit
8.9
value
6.9
group Id
OG002
lower Limit
5.5
upper Limit
8.8
value
6.7
denoms
counts
group Id
OG000
value
310
group Id
OG001
value
310
group Id
OG002
value
301
units
Participants
title
QLQ-C30 Dyspnea
categories
measurements
group Id
OG000
lower Limit
6.4
upper Limit
10.4
value
8.3
group Id
OG001
lower Limit
5.6
upper Limit
9.8
value
7.4
group Id
OG002
lower Limit
4.2
upper Limit
7.2
value
5.8
denoms
counts
group Id
OG000
value
311
group Id
OG001
value
304
group Id
OG002
value
301
units
Participants
title
QLQ-C30 Insomnia
categories
measurements
group Id
OG000
lower Limit
5.7
upper Limit
9.4
value
7.2
group Id
OG001
lower Limit
4.7
upper Limit
8.8
value
7.2
group Id
OG002
lower Limit
5.6
upper Limit
9.6
value
7.0
denoms
counts
group Id
OG000
value
308
group Id
OG001
value
316
group Id
OG002
value
305
units
Participants
title
QLQ-C30 Appetite Loss
denoms
counts
group Id
OG000
value
325
group Id
OG001
value
326
group Id
OG002
value
321
units
Participants
description
The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
dispersion Type
95% Confidence Interval
groups
description
During chemotherapy (combination) stage:
Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
id
OG000
title
T + D + SoC
description
During chemotherapy (combination) stage:
Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
id
OG001
title
D + SoC
description
During chemotherapy (combination) stage:
Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.
The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).
Post-chemotherapy (maintenance) stage:
Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.
id
OG002
title
SoC Alone
param Type
MEDIAN
population Description
Global cohort: The FAS included all randomized patients. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.
reporting Status
POSTED
time Frame
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever came first). Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).
title
Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
Triangle