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← Alunbrig: metastatic Non-small cell lung cancer with ALK stated without a specific alteration

NCT02737501 · STUDY IN CONTEXT

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

Draft scope assessment: unclear. Attached because the study's own record names ALK. 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

PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event.

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.

→

secondary · POSTED

ORR was defined as percentage of participants who achieved Complete response (CR) or Partial responses (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1 criteria. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to less than (\<) 10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.

→

secondary · POSTED

ORR was defined as percentage of participants who achieved CR or PR in the central nervous system (CNS) in randomized participants with intracranial CNS metastasis at baseline. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.

→

secondary · POSTED

Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.

→

secondary · POSTED

Overall survival is defined as the time from randomization until death due to any cause.

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.

→

secondary · POSTED

Duration of response as assessed by BIRC, is defined as the time interval from the date that the criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease (PD) is objectively documented. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30 % decrease in the SLD of target lesions, taking as reference the baseline sum diameters. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and for non-target lesions, unequivocal progression of existing non-target lesions.

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Only responders were reported for this outcome measure.

→

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 Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
nct id
NCT02737501
qol key
qol-0009
source section id
NCT02737501-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)
measure definition
HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.
time frame
Baseline and Month 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
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-alunbrig-fc7708ab
nct id
NCT02737501
trial label
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
applicability
unclear
applicability note
Attached because the study's own record names ALK. 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
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0000
    source section id
    NCT02737501-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event.
    time origin
    Up to end of study (Up to 56 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0001
    source section id
    NCT02737501-om-0001
    source outcome index
    1
    endpoint
    Confirmed Objective Response Rate (ORR)
    endpoint definition
    ORR was defined as percentage of participants who achieved Complete response (CR) or Partial responses (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1 criteria. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to less than (\<) 10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.
    time origin
    Baseline up to end of treatment (Up to 36 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0002
    source section id
    NCT02737501-om-0002
    source outcome index
    2
    endpoint
    Confirmed Intracranial ORR (iORR)
    endpoint definition
    ORR was defined as percentage of participants who achieved CR or PR in the central nervous system (CNS) in randomized participants with intracranial CNS metastasis at baseline. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.
    time origin
    Baseline up to end of treatment (Up to 36 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0003
    source section id
    NCT02737501-om-0003
    source outcome index
    3
    endpoint
    Intracranial Progression Free Survival
    endpoint definition
    Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.
    time origin
    Baseline up to end of study (Up to 56 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0004
    source section id
    NCT02737501-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival is defined as the time from randomization until death due to any cause.
    time origin
    Baseline up to end of study (Up to 56 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0005
    source section id
    NCT02737501-om-0005
    source outcome index
    5
    endpoint
    Duration of Response (DOR)
    endpoint definition
    Duration of response as assessed by BIRC, is defined as the time interval from the date that the criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease (PD) is objectively documented. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30 % decrease in the SLD of target lesions, taking as reference the baseline sum diameters. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and for non-target lesions, unequivocal progression of existing non-target lesions.
    time origin
    Baseline up to end of study (Up to 56 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Only responders were reported for this outcome measure.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Randomized Phase: Brigatinib 90 mg QD/180 QD
    regimen
    Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Randomized Phase: Crizotinib 250 mg BID
    regimen
    Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
    regimen
    Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Randomized Phase: Brigatinib 90 mg QD/180 QD
    regimen
    Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Randomized Phase: Crizotinib 250 mg BID
    regimen
    Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
    regimen
    Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Randomized Phase: Brigatinib 90 mg QD/180 QD
    regimen
    Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
    analyzed count
    47
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Randomized Phase: Crizotinib 250 mg BID
    regimen
    Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
    analyzed count
    49
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
    regimen
    Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Randomized Phase: Brigatinib 90 mg QD/180 QD
    regimen
    Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
    analyzed count
    47
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Randomized Phase: Crizotinib 250 mg BID
    regimen
    Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
    analyzed count
    49
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
    regimen
    Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02737501-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT02737501
    harm key
    EG000
    source section id
    NCT02737501-ae
    event group key
    EG000
    event group label
    Randomized Phase: Brigatinib 90 mg QD/180 QD
    serious affected
    56
    serious at risk
    136
    other affected
    132
    other at risk
    136
    frequency threshold
    5
    collection period
    All-Cause Mortality - Up to 56 months; Serious and other adverse events - From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
    event definition
    All Cause-mortality: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Serious and other (Non-serious): Treated Population included all participants who received ≥1 dose of study drug and served as basis of safety analysis. Crossover Population included participants from 'Crizotinib 250 mg BID' who crossed over to brigatinib following BIRC-assessed PD.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    harm key
    EG001
    source section id
    NCT02737501-ae
    event group key
    EG001
    event group label
    Randomized Phase: Crizotinib 250 mg BID
    serious affected
    53
    serious at risk
    137
    other affected
    135
    other at risk
    137
    frequency threshold
    5
    collection period
    All-Cause Mortality - Up to 56 months; Serious and other adverse events - From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
    event definition
    All Cause-mortality: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Serious and other (Non-serious): Treated Population included all participants who received ≥1 dose of study drug and served as basis of safety analysis. Crossover Population included participants from 'Crizotinib 250 mg BID' who crossed over to brigatinib following BIRC-assessed PD.
    undenominated note
    Source null
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    harm key
    EG002
    source section id
    NCT02737501-ae
    event group key
    EG002
    event group label
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
    serious affected
    24
    serious at risk
    65
    other affected
    63
    other at risk
    65
    frequency threshold
    5
    collection period
    All-Cause Mortality - Up to 56 months; Serious and other adverse events - From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
    event definition
    All Cause-mortality: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Serious and other (Non-serious): Treated Population included all participants who received ≥1 dose of study drug and served as basis of safety analysis. Crossover Population included participants from 'Crizotinib 250 mg BID' who crossed over to brigatinib following BIRC-assessed PD.
    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-alunbrig-fc7708ab
    nct id
    NCT02737501
    qol key
    qol-0009
    source section id
    NCT02737501-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)
    measure definition
    HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.
    time frame
    Baseline and Month 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
    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