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

NCT03833934 · STUDY IN CONTEXT

Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression

Source null

→

primary · POSTED

To determine the relative percentage of the ALK fusion within the cohort's gene pool

Patients with detected ALK fusion

→

primary · POSTED

To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS

Patients with detected ALK fusion

→

primary · POSTED

To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS

Patients with detected ALK fusion

→

primary · POSTED

To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS

Patients with detected ALK fusion

→

primary · POSTED

To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS

Patients with detected ALK fusion

→

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

No linked quality-of-life measure is recorded for this setting and study.

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
NCT03833934
trial label
Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance
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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    outcome key
    om-0000
    source section id
    NCT03833934-om-0000
    source outcome index
    0
    endpoint
    Prevalence of ALK Fusion
    endpoint definition
    To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression
    time origin
    32 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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
    NCT03833934
    outcome key
    om-0001
    source section id
    NCT03833934-om-0001
    source outcome index
    1
    endpoint
    ALK Fusion Allelic Frequency
    endpoint definition
    To determine the relative percentage of the ALK fusion within the cohort's gene pool
    time origin
    32 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with detected ALK fusion
    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
    NCT03833934
    outcome key
    om-0002
    source section id
    NCT03833934-om-0002
    source outcome index
    2
    endpoint
    Overall Prevalence of ALK Resistance Mechanism Among Patients With the ALK Fusion
    endpoint definition
    To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS
    time origin
    32 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with detected ALK fusion
    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
    NCT03833934
    outcome key
    om-0003
    source section id
    NCT03833934-om-0003
    source outcome index
    3
    endpoint
    Type of Resistance Mechanism: One or More Secondary ALK Kinase Domain Resistance Mutations
    endpoint definition
    To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
    time origin
    32 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with detected ALK fusion
    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
    NCT03833934
    outcome key
    om-0004
    source section id
    NCT03833934-om-0004
    source outcome index
    4
    endpoint
    Type of ALK Resistance Mechanism: Both ALK Resistance Mutations and Bypass Resistance
    endpoint definition
    To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
    time origin
    32 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with detected ALK fusion
    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
    NCT03833934
    outcome key
    om-0005
    source section id
    NCT03833934-om-0005
    source outcome index
    5
    endpoint
    Prevalance of ALK Restance Mechanism: Bypass Track Resistance
    endpoint definition
    To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
    time origin
    32 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with detected ALK fusion
    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
    NCT03833934
    outcome key
    om-0000
    arm key
    OG000
    arm label
    ALK-positive NSCLC With Progression
    regimen
    Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
    analyzed count
    62
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03833934-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    outcome key
    om-0001
    arm key
    OG000
    arm label
    ALK-positive NSCLC With Progression
    regimen
    Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03833934-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    outcome key
    om-0002
    arm key
    OG000
    arm label
    ALK-positive NSCLC With Progression
    regimen
    Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03833934-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    outcome key
    om-0003
    arm key
    OG000
    arm label
    ALK-positive NSCLC With Progression
    regimen
    Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03833934-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    outcome key
    om-0004
    arm key
    OG000
    arm label
    ALK-positive NSCLC With Progression
    regimen
    Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03833934-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    outcome key
    om-0005
    arm key
    OG000
    arm label
    ALK-positive NSCLC With Progression
    regimen
    Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03833934-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT03833934
    harm key
    EG000
    source section id
    NCT03833934-ae
    event group key
    EG000
    event group label
    ALK-positive NSCLC With Progression
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    Adverse event data not applicable for this study
    event definition
    Adverse event data not applicable for this study
    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
    setting source links

      Preserved source evidence · Not medical advice