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NCT04035486 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) (Randomized Component)

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) · Source last updated 2026-09-03

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

Measure
LEAST_SQUARES_MEAN
Unit
Scores on a Scale
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 33 months after the first patient is randomized.

What was measured

QLQ-C30 has 30 questions and scores range from 0-100 after a linear transformation. Questions are combined to produce symptom scales, individual symptom items, functional scales, and global health status (GHS)/quality of life (QoL). Positive change from baseline scores on the GHS/QoL and functioning scales indicate improvement on health status/function, and negative change scores on symptom scales/items represent less symptom severity/improvement on symptom status. The score values calculated by averaging across patients overall mean across all visits. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (random effect), treatment, visit (fixed effect \& repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction.

Analysis population: Full Analysis Set, includes all randomized participants.

Groups in this outcome

Randomized: AZD9291 + Chemo

Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W

Randomized: AZD9291

Osimertinib (AZD9291) 80mg QD.

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

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo253
Randomized: AZD9291253

Reported measurements

Functional Scale: Physical Functioning Score (Change from Baseline)
Values in Scores on a Scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo2.37Not reported0.704.04Not reported
Randomized: AZD92916.74Not reported5.048.43Not reported
Symptom Scale: Fatigue Score (Change from Baseline)
Values in Scores on a Scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo-0.03Not reported-1.911.84Not reported
Randomized: AZD9291-6.31Not reported-8.22-4.40Not reported
Individual Symptom Item: Appetite Loss Score (Change from Baseline)
Values in Scores on a Scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo2.87Not reported0.824.92Not reported
Randomized: AZD9291-4.58Not reported-6.67-2.48Not reported
Global Health Status/Quality of Life Score (Change from Baseline)
Values in Scores on a Scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo3.32Not reported1.674.98Not reported
Randomized: AZD92917.38Not reported5.709.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.70
        upper Limit
        4.04
        value
        2.37
      2. group Id
        OG001
        lower Limit
        5.04
        upper Limit
        8.43
        value
        6.74
    title
    Functional Scale: Physical Functioning Score (Change from Baseline)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.91
        upper Limit
        1.84
        value
        -0.03
      2. group Id
        OG001
        lower Limit
        -8.22
        upper Limit
        -4.40
        value
        -6.31
    title
    Symptom Scale: Fatigue Score (Change from Baseline)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.82
        upper Limit
        4.92
        value
        2.87
      2. group Id
        OG001
        lower Limit
        -6.67
        upper Limit
        -2.48
        value
        -4.58
    title
    Individual Symptom Item: Appetite Loss Score (Change from Baseline)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.67
        upper Limit
        4.98
        value
        3.32
      2. group Id
        OG001
        lower Limit
        5.70
        upper Limit
        9.07
        value
        7.38
    title
    Global Health Status/Quality of Life Score (Change from Baseline)
denoms
  1. counts
    1. group Id
      OG000
      value
      253
    2. group Id
      OG001
      value
      253
    units
    Participants
description
QLQ-C30 has 30 questions and scores range from 0-100 after a linear transformation. Questions are combined to produce symptom scales, individual symptom items, functional scales, and global health status (GHS)/quality of life (QoL). Positive change from baseline scores on the GHS/QoL and functioning scales indicate improvement on health status/function, and negative change scores on symptom scales/items represent less symptom severity/improvement on symptom status. The score values calculated by averaging across patients overall mean across all visits. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (random effect), treatment, visit (fixed effect \& repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction.
dispersion Type
95% Confidence Interval
groups
  1. description
    Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
    id
    OG000
    title
    Randomized: AZD9291 + Chemo
  2. description
    Osimertinib (AZD9291) 80mg QD.
    id
    OG001
    title
    Randomized: AZD9291
param Type
LEAST_SQUARES_MEAN
population Description
Full Analysis Set, includes all randomized participants.
reporting Status
POSTED
time Frame
Up to approximately 33 months after the first patient is randomized.
title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) (Randomized Component)
type
SECONDARY
unit Of Measure
Scores on a Scale

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Preserved source evidence · Not medical advice