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NCT04644237 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) · Source last updated 2025-11-21

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

Measure
MEAN
Unit
score on scale
Interval / dispersion
Standard Deviation
Time frame
At baseline and at end of treatment 40-day follow-up visit

What was measured

The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.

Analysis population: Full Analysis Set

Groups in this outcome

Trastuzumab Deruxtecan 5.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

Trastuzumab Deruxtecan 6.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

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

Analysis denominator · Participants

GroupSource count
Trastuzumab Deruxtecan 5.4 mg/kg102
Trastuzumab Deruxtecan 6.4 mg/kg50

Reported measurements

QLQ-C30: Change from Baseline 40-Day Follow-up
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg-1.1117.780Not reportedNot reportedNot reported
Trastuzumab Deruxtecan 6.4 mg/kg15.6331.947Not reportedNot reportedNot reported
QLQ-LC13: Change from Baseline 40-Day Follow-up
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg-2.3824.335Not reportedNot reportedNot reported
Trastuzumab Deruxtecan 6.4 mg/kg-29.1727.817Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.780
        value
        -1.11
      2. group Id
        OG001
        spread
        31.947
        value
        15.63
    title
    QLQ-C30: Change from Baseline 40-Day Follow-up
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.335
        value
        -2.38
      2. group Id
        OG001
        spread
        27.817
        value
        -29.17
    title
    QLQ-LC13: Change from Baseline 40-Day Follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    2. group Id
      OG001
      value
      50
    units
    Participants
description
The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.
dispersion Type
Standard Deviation
groups
  1. description
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    OG000
    title
    Trastuzumab Deruxtecan 5.4 mg/kg
  2. description
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    OG001
    title
    Trastuzumab Deruxtecan 6.4 mg/kg
param Type
MEAN
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
At baseline and at end of treatment 40-day follow-up visit
title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
type
SECONDARY
unit Of Measure
score on scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice