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← Docetaxel: metastatic Non-small cell lung cancer after prior therapy

NCT02014116 · STUDY IN CONTEXT

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body

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

Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.

All participants in Part A who received at least one dose of study drug.

→

secondary · POSTED

Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.

→

secondary · POSTED

PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.

All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.

→

secondary · POSTED

PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.

All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.

→

secondary · POSTED

PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.

All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.

→

secondary · POSTED

PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1.

All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.

→

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-docetaxel-62c51296
nct id
NCT02014116
trial label
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
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
9
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0000
    source section id
    NCT02014116-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose (MTD) of LY3009120
    endpoint definition
    Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
    time origin
    Cycle 1 (28 Days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants in Part A who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0001
    source section id
    NCT02014116-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Tumor Response
    endpoint definition
    Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
    time origin
    Baseline through progressive disease (Up to 7.36 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    source section id
    NCT02014116-om-0002
    source outcome index
    2
    endpoint
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
    endpoint definition
    PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
    time origin
    Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0003
    source section id
    NCT02014116-om-0003
    source outcome index
    3
    endpoint
    Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
    endpoint definition
    PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
    time origin
    Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0004
    source section id
    NCT02014116-om-0004
    source outcome index
    4
    endpoint
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
    endpoint definition
    PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
    time origin
    Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0005
    source section id
    NCT02014116-om-0005
    source outcome index
    5
    endpoint
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
    endpoint definition
    PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1.
    time origin
    Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Part A LY3009120
    regimen
    Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort A
    regimen
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort B
    regimen
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Cohort C
    regimen
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0001#groups/OG002
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    arm key
    OG000
    arm label
    50 mg LY3009120
    regimen
    50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    arm key
    OG001
    arm label
    100 mg LY3009120
    regimen
    100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    arm key
    OG002
    arm label
    200 mg LY3009120
    regimen
    200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    arm key
    OG003
    arm label
    300 mg LY3009120
    regimen
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0002#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    arm key
    OG004
    arm label
    400 mg LY3009120
    regimen
    400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0002#groups/OG004
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0002
    arm key
    OG005
    arm label
    500 mg LY3009120
    regimen
    500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0002#groups/OG005
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0003
    arm key
    OG000
    arm label
    50 mg LY3009120
    regimen
    50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0003#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    outcome key
    om-0003
    arm key
    OG001
    arm label
    100 mg LY3009120
    regimen
    100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02014116-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG000
    source section id
    NCT02014116-ae
    event group key
    EG000
    event group label
    Cohort 1
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG001
    source section id
    NCT02014116-ae
    event group key
    EG001
    event group label
    Cohort 2
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG002
    source section id
    NCT02014116-ae
    event group key
    EG002
    event group label
    Cohort 3
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG003
    source section id
    NCT02014116-ae
    event group key
    EG003
    event group label
    Cohort 4
    serious affected
    5
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG004
    source section id
    NCT02014116-ae
    event group key
    EG004
    event group label
    Cohort 5
    serious affected
    1
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG005
    source section id
    NCT02014116-ae
    event group key
    EG005
    event group label
    Cohort 6
    serious affected
    12
    serious at risk
    16
    other affected
    16
    other at risk
    16
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG006
    source section id
    NCT02014116-ae
    event group key
    EG006
    event group label
    Cohort A
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG007
    source section id
    NCT02014116-ae
    event group key
    EG007
    event group label
    Cohort B
    serious affected
    5
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT02014116
    harm key
    EG008
    source section id
    NCT02014116-ae
    event group key
    EG008
    event group label
    Cohort C
    serious affected
    6
    serious at risk
    10
    other affected
    9
    other at risk
    10
    frequency threshold
    5
    collection period
    Baseline to Study Completion (Up to 33 months)
    event definition
    All participants who received at least one dose of study drug.
    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