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NCT03043872 · OUTCOME

Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) · Source last updated 2026-07-16

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

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Error
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 comes first). Assessed up to 12 months.

What was measured

A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as \>75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.

Analysis population: The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.

Groups in this outcome

Global Cohort: D + EP

During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Global Cohort: EP

For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Global Cohort: D + EP261
Global Cohort: EP260

Reported measurements

EORTC QLQ-LC13 Cough

Analysis denominator · Participants

GroupSource count
Global Cohort: D + EP232
Global Cohort: EP232
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Global Cohort: D + EP-15.01.64Not reportedNot reportedNot reported
Global Cohort: EP-15.41.72Not reportedNot reportedNot reported
EORTC QLQ-LC13 Dyspnea

Analysis denominator · Participants

GroupSource count
Global Cohort: D + EP232
Global Cohort: EP232
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Global Cohort: D + EP-7.11.44Not reportedNot reportedNot reported
Global Cohort: EP-6.51.50Not reportedNot reportedNot reported
EORTC QLQ-LC13 Chest pain

Analysis denominator · Participants

GroupSource count
Global Cohort: D + EP232
Global Cohort: EP232
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Global Cohort: D + EP-7.81.59Not reportedNot reportedNot reported
Global Cohort: EP-7.21.65Not reportedNot reportedNot reported
EORTC QLQ-C30 Fatigue

Analysis denominator · Participants

GroupSource count
Global Cohort: D + EP233
Global Cohort: EP233
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Global Cohort: D + EP-5.81.62Not reportedNot reportedNot reported
Global Cohort: EP-4.51.69Not reportedNot reportedNot reported
EORTC QLQ-C30 Appetite loss

Analysis denominator · Participants

GroupSource count
Global Cohort: D + EP233
Global Cohort: EP233
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Global Cohort: D + EP-10.11.73Not reportedNot reportedNot reported
Global Cohort: EP-7.61.81Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.64
        value
        -15.0
      2. group Id
        OG001
        spread
        1.72
        value
        -15.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        232
      units
      Participants
    title
    EORTC QLQ-LC13 Cough
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.44
        value
        -7.1
      2. group Id
        OG001
        spread
        1.50
        value
        -6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        232
      units
      Participants
    title
    EORTC QLQ-LC13 Dyspnea
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.59
        value
        -7.8
      2. group Id
        OG001
        spread
        1.65
        value
        -7.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        232
      units
      Participants
    title
    EORTC QLQ-LC13 Chest pain
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.62
        value
        -5.8
      2. group Id
        OG001
        spread
        1.69
        value
        -4.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        233
      2. group Id
        OG001
        value
        233
      units
      Participants
    title
    EORTC QLQ-C30 Fatigue
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.73
        value
        -10.1
      2. group Id
        OG001
        spread
        1.81
        value
        -7.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        233
      2. group Id
        OG001
        value
        233
      units
      Participants
    title
    EORTC QLQ-C30 Appetite loss
denoms
  1. counts
    1. group Id
      OG000
      value
      261
    2. group Id
      OG001
      value
      260
    units
    Participants
description
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as \>75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
dispersion Type
Standard Error
groups
  1. description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    OG000
    title
    Global Cohort: D + EP
  2. description
    For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
    id
    OG001
    title
    Global Cohort: EP
param Type
MEAN
population Description
The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients 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 comes first). Assessed up to 12 months.
title
Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP
type
SECONDARY
unit Of Measure
scores on a scale

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Preserved source evidence · Not medical advice