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NCT04035486 · OUTCOME

Median Time to Deterioration 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 33 months after the first patient is randomized.

What was measured

The EORTC QLQ-C30 consists of 30 questions that are combined to produce 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), 5 functional scales (physical, role, cognitive, emotional, and social), and a global measure of health status/QoL. Scores range from 0-100 after a linear transformation. Time to deterioration (TTD) is defined as the time from randomization until the date of the first clinically meaningful worsening (a change in the score from baseline of ≥10) that is confirmed at a subsequent assessment or death in the absence of a clinically meaningful symptom, function, or global health status/QoL worsening, regardless of whether the patient withdraws from study treatment or receives another anticancer therapy prior to symptom, function or GHS/QoL deterioration. The median TTD was calculated using the Kaplan-Meier method.

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 + Chemo279
Randomized: AZD9291278

Reported measurements

Median TTD for Physical Functioning Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo25.5Not reported17.2NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Randomized: AZD9291NANot reported29.6NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Median TTD for Role Functioning Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo13.1Not reported8.922.8Not reported
Randomized: AZD929121.9Not reported18.2NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Median TTD for Cognitive Functioning Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo15.7Not reported10.121.5Not reported
Randomized: AZD929120.0Not reported15.425.5Not reported
Median TTD for Emotional Functioning Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo29.6Not reported25.2NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Randomized: AZD9291NANot reportedNANAMedian TTD, Lower Limit and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Median TTD for Social Functioning Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo19.3Not reported11.727.8Not reported
Randomized: AZD929128.4Not reported20.6NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Median TTD for Fatigue Symptom Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo5.9Not reported2.611.8Not reported
Randomized: AZD929120.0Not reported13.828.4Not reported
Median TTD for Pain Symptom Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo28.0Not reported21.5NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Randomized: AZD929124.6Not reported20.0NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Median TTD for Nausea/Vomiting Symptom Scale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo20.5Not reported13.2NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Randomized: AZD929130.5Not reported23.4NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Median TTD for Dyspnea Symptom Item (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + ChemoNANot reported25.8NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Randomized: AZD9291NANot reported21.9NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Median TTD for Insomnia Symptom Item (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + ChemoNANot reported27.7NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Randomized: AZD9291NANot reported23.4NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Median TTD for Appetite Loss Symptom Item (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo10.1Not reported5.123.0Not reported
Randomized: AZD929128.4Not reported21.0NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Median TTD for Constipation Symptom Item (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo21.7Not reported15.9NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Randomized: AZD9291NANot reported23.8NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Median TTD for Diarrhea Symptom Item (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo7.8Not reported4.411.9Not reported
Randomized: AZD92917.7Not reported4.616.9Not reported
Median TTD for Global Health Status/Quality of Life (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo25.8Not reported20.1NAUpper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Randomized: AZD9291NANot reported24.6NAMedian TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG000
        lower Limit
        17.2
        upper Limit
        NA
        value
        25.5
      2. comment
        Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG001
        lower Limit
        29.6
        upper Limit
        NA
        value
        NA
    title
    Median TTD for Physical Functioning Scale (months)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.9
        upper Limit
        22.8
        value
        13.1
      2. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG001
        lower Limit
        18.2
        upper Limit
        NA
        value
        21.9
    title
    Median TTD for Role Functioning Scale (months)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.1
        upper Limit
        21.5
        value
        15.7
      2. group Id
        OG001
        lower Limit
        15.4
        upper Limit
        25.5
        value
        20.0
    title
    Median TTD for Cognitive Functioning Scale (months)
  4. categories
    1. measurements
      1. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG000
        lower Limit
        25.2
        upper Limit
        NA
        value
        29.6
      2. comment
        Median TTD, Lower Limit and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Median TTD for Emotional Functioning Scale (months)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.7
        upper Limit
        27.8
        value
        19.3
      2. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG001
        lower Limit
        20.6
        upper Limit
        NA
        value
        28.4
    title
    Median TTD for Social Functioning Scale (months)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.6
        upper Limit
        11.8
        value
        5.9
      2. group Id
        OG001
        lower Limit
        13.8
        upper Limit
        28.4
        value
        20.0
    title
    Median TTD for Fatigue Symptom Scale (months)
  7. categories
    1. measurements
      1. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG000
        lower Limit
        21.5
        upper Limit
        NA
        value
        28.0
      2. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG001
        lower Limit
        20.0
        upper Limit
        NA
        value
        24.6
    title
    Median TTD for Pain Symptom Scale (months)
  8. categories
    1. measurements
      1. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG000
        lower Limit
        13.2
        upper Limit
        NA
        value
        20.5
      2. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG001
        lower Limit
        23.4
        upper Limit
        NA
        value
        30.5
    title
    Median TTD for Nausea/Vomiting Symptom Scale (months)
  9. categories
    1. measurements
      1. comment
        Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG000
        lower Limit
        25.8
        upper Limit
        NA
        value
        NA
      2. comment
        Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG001
        lower Limit
        21.9
        upper Limit
        NA
        value
        NA
    title
    Median TTD for Dyspnea Symptom Item (months)
  10. categories
    1. measurements
      1. comment
        Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG000
        lower Limit
        27.7
        upper Limit
        NA
        value
        NA
      2. comment
        Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG001
        lower Limit
        23.4
        upper Limit
        NA
        value
        NA
    title
    Median TTD for Insomnia Symptom Item (months)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.1
        upper Limit
        23.0
        value
        10.1
      2. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG001
        lower Limit
        21.0
        upper Limit
        NA
        value
        28.4
    title
    Median TTD for Appetite Loss Symptom Item (months)
  12. categories
    1. measurements
      1. comment
        Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG000
        lower Limit
        15.9
        upper Limit
        NA
        value
        21.7
      2. comment
        Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.
        group Id
        OG001
        lower Limit
        23.8
        upper Limit
        NA
        value
        NA
    title
    Median TTD for Constipation Symptom Item (months)
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      278
    units
    Participants
description
The EORTC QLQ-C30 consists of 30 questions that are combined to produce 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), 5 functional scales (physical, role, cognitive, emotional, and social), and a global measure of health status/QoL. Scores range from 0-100 after a linear transformation. Time to deterioration (TTD) is defined as the time from randomization until the date of the first clinically meaningful worsening (a change in the score from baseline of ≥10) that is confirmed at a subsequent assessment or death in the absence of a clinically meaningful symptom, function, or global health status/QoL worsening, regardless of whether the patient withdraws from study treatment or receives another anticancer therapy prior to symptom, function or GHS/QoL deterioration. The median TTD was calculated using the Kaplan-Meier method.
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
MEDIAN
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
Median Time to Deterioration 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
Months

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Preserved source evidence · Not medical advice