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← BIZENGRI: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration after prior therapy

NCT04644237 · STUDY IN CONTEXT

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Full Analysis Set includes all subjects for whom study treatment was assigned by randomization

→

secondary · POSTED

Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Full Analysis Set includes all subjects for whom study treatment was assigned by randomization

→

secondary · POSTED

Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Full Analysis Set includes all subjects for whom study treatment was assigned by randomization. From the Full Analysis Set, 47 participants had a confirmed CR or PR in T-DXd 5.4 mg/kg arm, and 28 participants in T-DXd 6.4 mg/kg arm

→

secondary · POSTED

Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Full Analysis Set includes all subjects for whom study treatment was assigned by randomization

→

secondary · POSTED

Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.

Full Analysis Set includes all subjects for whom study treatment was assigned by randomization

→

secondary · POSTED

Overall survival (OS) is defined as the time from date of randomization until death from any cause.

Full Analysis Set

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · 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

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-4710e9b9
nct id
NCT04644237
qol key
qol-0011
source section id
NCT04644237-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale 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
measure definition
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.
time frame
At baseline and at end of treatment 40-day follow-up visit
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores for functioning scales and global health status indicate a better
population note
Full Analysis Set
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-4710e9b9
nct id
NCT04644237
qol key
qol-0012
source section id
NCT04644237-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
measure definition
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.
time frame
At baseline and at end of treatment 40-day follow-up visit
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores for functioning scales and global health status indicate a better
population note
Full Analysis Set
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-4710e9b9
nct id
NCT04644237
trial label
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
applicability
unclear
applicability note
Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0000
    source section id
    NCT04644237-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants With Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
    endpoint definition
    Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    time origin
    9 months after the last participant is randomized to data cut off, up to approximately 21 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0001
    source section id
    NCT04644237-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants With Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerTumors
    endpoint definition
    Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    time origin
    9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0002
    source section id
    NCT04644237-om-0002
    source outcome index
    2
    endpoint
    Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
    endpoint definition
    Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    time origin
    9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set includes all subjects for whom study treatment was assigned by randomization. From the Full Analysis Set, 47 participants had a confirmed CR or PR in T-DXd 5.4 mg/kg arm, and 28 participants in T-DXd 6.4 mg/kg arm
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0003
    source section id
    NCT04644237-om-0003
    source outcome index
    3
    endpoint
    Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
    endpoint definition
    Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
    time origin
    9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0004
    source section id
    NCT04644237-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
    endpoint definition
    Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.
    time origin
    9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0005
    source section id
    NCT04644237-om-0005
    source outcome index
    5
    endpoint
    Overall Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
    endpoint definition
    Overall survival (OS) is defined as the time from date of randomization until death from any cause.
    time origin
    9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Trastuzumab Deruxtecan 5.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Trastuzumab Deruxtecan 6.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Trastuzumab Deruxtecan 5.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Trastuzumab Deruxtecan 6.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Trastuzumab Deruxtecan 5.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    47
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Trastuzumab Deruxtecan 6.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Trastuzumab Deruxtecan 5.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Trastuzumab Deruxtecan 6.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Trastuzumab Deruxtecan 5.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Trastuzumab Deruxtecan 6.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Trastuzumab Deruxtecan 5.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Trastuzumab Deruxtecan 6.4 mg/kg
    regimen
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644237-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    harm key
    EG000
    source section id
    NCT04644237-ae
    event group key
    EG000
    event group label
    Trastuzumab Deruxtecan 5.4 mg/kg
    serious affected
    42
    serious at risk
    101
    other affected
    101
    other at risk
    101
    frequency threshold
    5
    collection period
    Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
    event definition
    A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    harm key
    EG001
    source section id
    NCT04644237-ae
    event group key
    EG001
    event group label
    Trastuzumab Deruxtecan 6.4 mg/kg
    serious affected
    26
    serious at risk
    50
    other affected
    50
    other at risk
    50
    frequency threshold
    5
    collection period
    Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
    event definition
    A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    qol key
    qol-0011
    source section id
    NCT04644237-om-0011
    source outcome index
    11
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale 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
    measure definition
    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.
    time frame
    At baseline and at end of treatment 40-day follow-up visit
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores for functioning scales and global health status indicate a better
    population note
    Full Analysis Set
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-4710e9b9
    nct id
    NCT04644237
    qol key
    qol-0012
    source section id
    NCT04644237-om-0012
    source outcome index
    12
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
    measure definition
    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.
    time frame
    At baseline and at end of treatment 40-day follow-up visit
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores for functioning scales and global health status indicate a better
    population note
    Full Analysis Set
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice