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-beizray-84b0e755
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-beizray-84b0e755
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