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NCT04035486 · OUTCOME

Time to Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC13) (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

EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Questions assess cough, hemoptysis, dyspnea, site specific pain, sore mouth, dysphagia, peripheral neuropathy, and alopecia and pain medication. 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, 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 Coughing Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + ChemoNANot reported30.4NAMedian 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.
Randomized: AZD929124.7Not reported21.3NAUpper 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 Haemoptysis Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + ChemoNANot 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.
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 Dysphagia Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo25.6Not reported20.8NAUpper 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 reported23.4NAMedian 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 Pain in arm or shoulder Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo25.2Not reported20.2NAUpper 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: AZD929123.8Not 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 Pain in other parts Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo23.0Not reported15.7NAUpper 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: AZD929121.3Not 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 Pain in Chest Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + ChemoNANot reported25.7NAMedian 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 reported25.2NAMedian 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 Sore mouth Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo4.3Not reported2.17.0Not reported
Randomized: AZD92915.8Not reported4.19.7Not reported
Median TTD for Dyspnea Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo9.0Not reported5.613.1Not reported
Randomized: AZD929119.4Not reported13.724.6Not reported
Median TTD for Peripheral neuropathy Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo11.3Not reported7.115.7Not reported
Randomized: AZD929115.1Not reported9.718.2Not reported
Median TTD for Alopecia Subscale (months)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo3.4Not reported2.84.3Not reported
Randomized: AZD92918.9Not reported5.718.2Not reported
Complete source fields
classes
  1. 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
        30.4
        upper Limit
        NA
        value
        NA
      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
        21.3
        upper Limit
        NA
        value
        24.7
    title
    Median TTD for Coughing Subscale (months)
  2. categories
    1. measurements
      1. 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
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      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 Haemoptysis Subscale (months)
  3. 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
        20.8
        upper Limit
        NA
        value
        25.6
      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 Dysphagia Subscale (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
        20.2
        upper Limit
        NA
        value
        25.2
      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
        23.8
    title
    Median TTD for Pain in arm or shoulder Subscale (months)
  5. 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
        15.7
        upper Limit
        NA
        value
        23.0
      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
        18.2
        upper Limit
        NA
        value
        21.3
    title
    Median TTD for Pain in other parts Subscale (months)
  6. 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
        25.7
        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
        25.2
        upper Limit
        NA
        value
        NA
    title
    Median TTD for Pain in Chest Subscale (months)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        7.0
        value
        4.3
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        9.7
        value
        5.8
    title
    Median TTD for Sore mouth Subscale (months)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.6
        upper Limit
        13.1
        value
        9.0
      2. group Id
        OG001
        lower Limit
        13.7
        upper Limit
        24.6
        value
        19.4
    title
    Median TTD for Dyspnea Subscale (months)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.1
        upper Limit
        15.7
        value
        11.3
      2. group Id
        OG001
        lower Limit
        9.7
        upper Limit
        18.2
        value
        15.1
    title
    Median TTD for Peripheral neuropathy Subscale (months)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        4.3
        value
        3.4
      2. group Id
        OG001
        lower Limit
        5.7
        upper Limit
        18.2
        value
        8.9
    title
    Median TTD for Alopecia Subscale (months)
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      278
    units
    Participants
description
EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Questions assess cough, hemoptysis, dyspnea, site specific pain, sore mouth, dysphagia, peripheral neuropathy, and alopecia and pain medication. 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, all randomized participants.
reporting Status
POSTED
time Frame
Up to approximately 33 months after the first patient is randomized.
title
Time to Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC13) (Randomized Component)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice