NCT04334759 · OUTCOME
Health-Related Quality of Life (QOL): LC29
DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma · Source last updated 2026-10-01
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
- Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks until disease progression and at first progression visit (minimum follow-up is 24 months after randomisation).
What was measured
EORTC Quality of Life Lung Cancer Module (QLQ-LC29), Importance of QOL issues assessed using a four-point scale (1 = not at all, 4 = very much) and transformed to a 0-100 score, where higher scores mean worse possible symptom burden or severe impact.
Analysis population: The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.
Groups in this outcome
Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Control Arm for Chemo Cohort: Chemotherapy, Then Observation
Standard Chemotherapy for 4 to 6 cycles, followed by Observation
Standard Chemotherapy: Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Control Arm for IO Cohort: Ipilimumab and Nivolumab
Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
Ipilimumab and Nivolumab: Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
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 |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 109 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 57 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 15 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 22 |
|---|
Reported measurements
At baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 109 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 57 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 15 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 22 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 67.9 | 19.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 67.8 | 19.6 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 66.9 | 26.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 59.3 | 18.1 | Not reported | Not reported | Not reported |
|---|
At week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 91 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 48 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 15 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 64.2 | 19.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 63.4 | 23.4 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 63.3 | 22.4 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 61.8 | 18.9 | Not reported | Not reported | Not reported |
|---|
At week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 90 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 38 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 13 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 16 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 64.6 | 19.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 61.3 | 22.8 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 56.4 | 23.1 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 67.7 | 14.2 | Not reported | Not reported | Not reported |
|---|
At week 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 89 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 34 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 10 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 18 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 61.8 | 20.7 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 61.5 | 21.6 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 70.4 | 21.9 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 68.1 | 14.6 | Not reported | Not reported | Not reported |
|---|
At week 26
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 88 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 30 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 11 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 16 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 65.1 | 22.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 69 | 21.3 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 76.9 | 21.7 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 66.1 | 18.9 | Not reported | Not reported | Not reported |
|---|
At week 34
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 68 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 22 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 8 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 13 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 72.6 | 17.3 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 66.7 | 22.4 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 72.4 | 16.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 70.5 | 13 | Not reported | Not reported | Not reported |
|---|
At week 42
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 49 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 10 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 6 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 12 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 67.3 | 19.7 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 65 | 23.2 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 77.8 | 19.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 65.3 | 17.1 | Not reported | Not reported | Not reported |
|---|
At week 50
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 41 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 9 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 6 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 11 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 72 | 15.4 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 70.8 | 18.6 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 72.2 | 19.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 65.5 | 17.1 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.6
- value
- 67.9
- group Id
- OG001
- spread
- 19.6
- value
- 67.8
- group Id
- OG002
- spread
- 26.6
- value
- 66.9
- group Id
- OG003
- spread
- 18.1
- value
- 59.3
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 22
- units
- Participants
- title
- At baseline
- categories
- measurements
- group Id
- OG000
- spread
- 19.5
- value
- 64.2
- group Id
- OG001
- spread
- 23.4
- value
- 63.4
- group Id
- OG002
- spread
- 22.4
- value
- 63.3
- group Id
- OG003
- spread
- 18.9
- value
- 61.8
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 48
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 17
- units
- Participants
- title
- At week 6
- categories
- measurements
- group Id
- OG000
- spread
- 19.6
- value
- 64.6
- group Id
- OG001
- spread
- 22.8
- value
- 61.3
- group Id
- OG002
- spread
- 23.1
- value
- 56.4
- group Id
- OG003
- spread
- 14.2
- value
- 67.7
- denoms
- counts
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 16
- units
- Participants
- title
- At week 12
- categories
- measurements
- group Id
- OG000
- spread
- 20.7
- value
- 61.8
- group Id
- OG001
- spread
- 21.6
- value
- 61.5
- group Id
- OG002
- spread
- 21.9
- value
- 70.4
- group Id
- OG003
- spread
- 14.6
- value
- 68.1
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 18
- units
- Participants
- title
- At week 18
- categories
- measurements
- group Id
- OG000
- spread
- 22.5
- value
- 65.1
- group Id
- OG001
- spread
- 21.3
- value
- 69
- group Id
- OG002
- spread
- 21.7
- value
- 76.9
- group Id
- OG003
- spread
- 18.9
- value
- 66.1
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 16
- units
- Participants
- title
- At week 26
- categories
- measurements
- group Id
- OG000
- spread
- 17.3
- value
- 72.6
- group Id
- OG001
- spread
- 22.4
- value
- 66.7
- group Id
- OG002
- spread
- 16.5
- value
- 72.4
- group Id
- OG003
- spread
- 13
- value
- 70.5
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 13
- units
- Participants
- title
- At week 34
- categories
- measurements
- group Id
- OG000
- spread
- 19.7
- value
- 67.3
- group Id
- OG001
- spread
- 23.2
- value
- 65
- group Id
- OG002
- spread
- 19.5
- value
- 77.8
- group Id
- OG003
- spread
- 17.1
- value
- 65.3
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 12
- units
- Participants
- title
- At week 42
- categories
- measurements
- group Id
- OG000
- spread
- 15.4
- value
- 72
- group Id
- OG001
- spread
- 18.6
- value
- 70.8
- group Id
- OG002
- spread
- 19.5
- value
- 72.2
- group Id
- OG003
- spread
- 17.1
- value
- 65.5
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 11
- units
- Participants
- title
- At week 50
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 22
- units
- Participants
- description
- EORTC Quality of Life Lung Cancer Module (QLQ-LC29), Importance of QOL issues assessed using a four-point scale (1 = not at all, 4 = very much) and transformed to a 0-100 score, where higher scores mean worse possible symptom burden or severe impact.
- dispersion Type
- Standard Deviation
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
- id
- OG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation
Standard Chemotherapy: Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
- id
- OG001
- title
- Control Arm for Chemo Cohort: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
- id
- OG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
Ipilimumab and Nivolumab: Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
- id
- OG003
- title
- Control Arm for IO Cohort: Ipilimumab and Nivolumab
- param Type
- MEAN
- population Description
- The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.
- reporting Status
- POSTED
- time Frame
- Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks until disease progression and at first progression visit (minimum follow-up is 24 months after randomisation).
- title
- Health-Related Quality of Life (QOL): LC29
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
Triangle