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← Gemcitabine: metastatic Non-small cell lung cancer (first-line)

NCT01327612 · STUDY IN CONTEXT

Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)

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

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.

Participants who received at least one dose of conatumumab or ganitumab.

→

primary · POSTED

A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.

Participants who received at least one dose of conatumumab or ganitumab.

→

secondary · POSTED

Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.

Participants who received at least one dose of conatumumab or ganitumab.

→

secondary · POSTED

Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.

Participants who received at least one dose of conatumumab or ganitumab.

→

secondary · POSTED

Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Participants who received at least one dose of conatumumab or ganitumab.

→

secondary · POSTED

Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.

Participants who received at least one dose of conatumumab or ganitumab.

→

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-gemcitabine-2de74d12
nct id
NCT01327612
trial label
Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
applicability
unclear
applicability note
Attached because the study's own record 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
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
7
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    source section id
    NCT01327612-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Adverse Events
    endpoint definition
    An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
    time origin
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one dose of conatumumab or ganitumab.
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0001
    source section id
    NCT01327612-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Serious Adverse Events
    endpoint definition
    A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.
    time origin
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one dose of conatumumab or ganitumab.
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0002
    source section id
    NCT01327612-om-0002
    source outcome index
    2
    endpoint
    Maximum Change From Baseline in Blood Pressure
    endpoint definition
    Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
    time origin
    Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one dose of conatumumab or ganitumab.
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0003
    source section id
    NCT01327612-om-0003
    source outcome index
    3
    endpoint
    Minimum Change From Baseline in Blood Pressure
    endpoint definition
    Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.
    time origin
    Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one dose of conatumumab or ganitumab.
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0004
    source section id
    NCT01327612-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
    endpoint definition
    Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
    time origin
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one dose of conatumumab or ganitumab.
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0005
    source section id
    NCT01327612-om-0005
    source outcome index
    5
    endpoint
    Best Overall Response
    endpoint definition
    Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.
    time origin
    Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one dose of conatumumab or ganitumab.
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG000
    arm label
    20050118: Ganitumab 20 mg/kg
    regimen
    Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG001
    arm label
    20050171: Conatumumab 0.45 mg/kg
    regimen
    Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG002
    arm label
    20060295: Conatumumab 3 mg/kg
    regimen
    Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG003
    arm label
    20060340: Conatumumab 5 mg/kg
    regimen
    Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG004
    arm label
    20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
    regimen
    Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG005
    arm label
    20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
    regimen
    Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0000
    arm key
    OG006
    arm label
    20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
    regimen
    Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0001
    arm key
    OG000
    arm label
    20050118: Ganitumab 20 mg/kg
    regimen
    Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0001#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0001
    arm key
    OG001
    arm label
    20050171: Conatumumab 0.45 mg/kg
    regimen
    Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0001#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0001
    arm key
    OG002
    arm label
    20060295: Conatumumab 3 mg/kg
    regimen
    Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0001#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0001
    arm key
    OG003
    arm label
    20060340: Conatumumab 5 mg/kg
    regimen
    Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0001#groups/OG003
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    outcome key
    om-0001
    arm key
    OG004
    arm label
    20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
    regimen
    Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01327612-om-0001#groups/OG004
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG000
    source section id
    NCT01327612-ae
    event group key
    EG000
    event group label
    20050118: Ganitumab 20 mg/kg
    serious affected
    1
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG001
    source section id
    NCT01327612-ae
    event group key
    EG001
    event group label
    20050171: Conatumumab 0.45 mg/kg
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG002
    source section id
    NCT01327612-ae
    event group key
    EG002
    event group label
    20060295: Conatumumab 3 mg/kg
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG003
    source section id
    NCT01327612-ae
    event group key
    EG003
    event group label
    20060340: Conatumumab 5 mg/kg
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG004
    source section id
    NCT01327612-ae
    event group key
    EG004
    event group label
    20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
    serious affected
    1
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    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-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG005
    source section id
    NCT01327612-ae
    event group key
    EG005
    event group label
    20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
    serious affected
    3
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-gemcitabine-2de74d12
    nct id
    NCT01327612
    harm key
    EG006
    source section id
    NCT01327612-ae
    event group key
    EG006
    event group label
    20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
    serious affected
    2
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    5
    collection period
    From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
    event definition
    Source null
    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