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

NCT01871805 · STUDY IN CONTEXT

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

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

The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (\>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of \>=7 days which the Investigator could not rule out as been related to alectinib.

Phase I safety population

→

primary · POSTED

RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.

Phase I safety population

→

primary · POSTED

Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).

Phase II Response evaluable (RE) population comprised all Phase II participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.

→

secondary · POSTED

Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.

Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.

→

secondary · POSTED

DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.

Phase I RE population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.

→

secondary · POSTED

Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.

Phase II RE population

→

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) Quality of Life Questionnaire (QLQ-C30): Phase II

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-alunbrig-fc7708ab
nct id
NCT01871805
qol key
qol-0026
source section id
NCT01871805-om-0026
source outcome index
26
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) Quality of Life Questionnaire (QLQ-C30): Phase II
measure definition
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL \[quality of life\]) represents absolute data at baseline. QoL=quality of life
time frame
Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score=better
population note
Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II

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-alunbrig-fc7708ab
nct id
NCT01871805
qol key
qol-0027
source section id
NCT01871805-om-0027
source outcome index
27
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II
measure definition
EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.
time frame
Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score=better
population note
Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.
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
NCT01871805
trial label
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
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
6
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0000
    source section id
    NCT01871805-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Dose Limiting Toxicities (DLTs): Phase I
    endpoint definition
    The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (\>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of \>=7 days which the Investigator could not rule out as been related to alectinib.
    time origin
    Throughout Cycle 1 of Phase I (21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase I safety population
    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
    NCT01871805
    outcome key
    om-0001
    source section id
    NCT01871805-om-0001
    source outcome index
    1
    endpoint
    Recommended Phase II Dose (RP2D): Phase I
    endpoint definition
    RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.
    time origin
    Throughout Cycle 1 of Phase I (21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase I safety population
    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
    NCT01871805
    outcome key
    om-0002
    source section id
    NCT01871805-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II
    endpoint definition
    Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).
    time origin
    Cycle 1 Day 1 up to 194 weeks (assessed at every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter) (1 cycle = 21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase II Response evaluable (RE) population comprised all Phase II participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.
    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
    NCT01871805
    outcome key
    om-0003
    source section id
    NCT01871805-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I
    endpoint definition
    Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
    time origin
    Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.
    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
    NCT01871805
    outcome key
    om-0004
    source section id
    NCT01871805-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I
    endpoint definition
    DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
    time origin
    Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase I RE population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
    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
    NCT01871805
    outcome key
    om-0005
    source section id
    NCT01871805-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II
    endpoint definition
    Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.
    time origin
    Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase II RE population
    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
    NCT01871805
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Alectinib 300 mg (Fasted): Phase I
    regimen
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Alectinib 460 mg (Fed): Phase I
    regimen
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Alectinib 760 mg (Fed): Phase I
    regimen
    Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Alectinib 900 mg (Fed): Phase I (20/40/150 mg)
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Alectinib: Phase I
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 600, 760, or 900 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    47
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0001#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Alectinib 600 mg (Fed): Phase II
    regimen
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    67
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Alectinib Other Than 600 mg (Fasted/Fed): Phase I
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0004#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Alectinib Other Than 600 mg (Fasted/Fed): Phase I
    regimen
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-om-0004#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-alunbrig-fc7708ab
    nct id
    NCT01871805
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Alectinib 600 mg (Fed): Phase II
    regimen
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    analyzed count
    87
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01871805-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
    NCT01871805
    harm key
    EG000
    source section id
    NCT01871805-ae
    event group key
    EG000
    event group label
    Alectinib 300 mg (Fasted): Phase I
    serious affected
    1
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
    event definition
    Safety population
    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
    NCT01871805
    harm key
    EG001
    source section id
    NCT01871805-ae
    event group key
    EG001
    event group label
    Alectinib 460 mg (Fed): Phase I
    serious affected
    2
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
    event definition
    Safety population
    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
    NCT01871805
    harm key
    EG002
    source section id
    NCT01871805-ae
    event group key
    EG002
    event group label
    Alectinib 600 mg (Fed): Phase I
    serious affected
    6
    serious at risk
    13
    other affected
    12
    other at risk
    13
    frequency threshold
    5
    collection period
    Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
    event definition
    Safety population
    undenominated note
    Source null
    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
    NCT01871805
    harm key
    EG003
    source section id
    NCT01871805-ae
    event group key
    EG003
    event group label
    Alectinib 760 mg (Fed): Phase I
    serious affected
    0
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
    event definition
    Safety population
    undenominated note
    Source null
    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
    NCT01871805
    harm key
    EG004
    source section id
    NCT01871805-ae
    event group key
    EG004
    event group label
    Alectinib 900 mg (Fed): Phase I
    serious affected
    1
    serious at risk
    13
    other affected
    13
    other at risk
    13
    frequency threshold
    5
    collection period
    Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
    event definition
    Safety population
    undenominated note
    Source null
    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
    NCT01871805
    harm key
    EG005
    source section id
    NCT01871805-ae
    event group key
    EG005
    event group label
    Alectinib 600 mg (Fed): Phase II
    serious affected
    21
    serious at risk
    87
    other affected
    85
    other at risk
    87
    frequency threshold
    5
    collection period
    Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
    event definition
    Safety population
    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
    NCT01871805
    qol key
    qol-0026
    source section id
    NCT01871805-om-0026
    source outcome index
    26
    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) Quality of Life Questionnaire (QLQ-C30): Phase II
    measure definition
    EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL \[quality of life\]) represents absolute data at baseline. QoL=quality of life
    time frame
    Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score=better
    population note
    Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.
    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
    NCT01871805
    qol key
    qol-0027
    source section id
    NCT01871805-om-0027
    source outcome index
    27
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II
    measure definition
    EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.
    time frame
    Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score=better
    population note
    Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.
    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