A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

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

DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.

All participants who received at least one dose of study drug and had a dose limiting toxicity.

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primary · POSTED

ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.

Zero participants were analyzed due to early termination of study.

→

primary · POSTED

PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) or death without documented disease progression per RECIST V1.1 criteria.

Zero participants were analyzed due to early termination of study.

→

secondary · POSTED

Average concentration after the first dose of LY3499446.

All participants who have received at least one dose of study drug and had evaluable PK.

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secondary · POSTED

PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib

Zero participants were analyzed due to early termination of study.

→

secondary · POSTED

PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab

Zero participants were analyzed due to early termination of study.

→

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-lumakras-1056c141
nct id: NCT04165031
trial label: A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
applicability: unclear
applicability note: Attached because the study's own record names KRAS. 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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0000
source section id
NCT04165031-om-0000
source outcome index
0
endpoint
Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)
endpoint definition
DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.
time origin
Cycle 1 (21 Day Cycle)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least one dose of study drug and had a dose limiting toxicity.
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-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0001
source section id
NCT04165031-om-0001
source outcome index
1
endpoint
Phase 2: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) in Colorectal Cancer (CRC) Cohorts and Other Tumors Cohort
endpoint definition
ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
time origin
Baseline through Measured Progressive Disease
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed due to early termination of study.
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-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0002
source section id
NCT04165031-om-0002
source outcome index
2
endpoint
Phase 2: Progression-Free Survival (PFS) Non-Small Lung Cancer (NSCLC Cohorts)
endpoint definition
PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) or death without documented disease progression per RECIST V1.1 criteria.
time origin
Baseline to Objective Progression or Death Due to Any Cause
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed due to early termination of study.
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-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0003
source section id
NCT04165031-om-0003
source outcome index
3
endpoint
Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446
endpoint definition
Average concentration after the first dose of LY3499446.
time origin
Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who have received at least one dose of study drug and had evaluable PK.
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-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0004
source section id
NCT04165031-om-0004
source outcome index
4
endpoint
Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Abemaciclib
endpoint definition
PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
time origin
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed due to early termination of study.
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-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0005
source section id
NCT04165031-om-0005
source outcome index
5
endpoint
Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Cetuximab
endpoint definition
PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
time origin
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Zero participants were analyzed due to early termination of study.
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-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0000
arm key
OG000
arm label
LY3499446 Phase 1 Cohort A1 (High Dose)
regimen
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0000
arm key
OG001
arm label
LY3499446 Phase 1 Cohort AO (Mid Dose)
regimen
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0000
arm key
OG002
arm label
LY3499446 Phase 1 Cohort A-2 (Low Dose)
regimen
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0001
arm key
OG000
arm label
LY3499446 Monotherapy + Combination Drugs Phase 2
regimen
LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0001
arm key
OG001
arm label
Docetaxel Phase 2
regimen
Docetaxel IV infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0002
arm key
OG000
arm label
LY3499446 Monotherapy + Combination Drugs Phase 2
regimen
LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0002
arm key
OG001
arm label
Docetaxel Phase 2
regimen
Docetaxel IV infusion.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0003
arm key
OG000
arm label
LY3499446 Phase 1 Cohort A1 (High Dose)
regimen
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0003
arm key
OG001
arm label
LY3499446 Phase 1 Cohort AO (Mid Dose)
regimen
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0003
arm key
OG002
arm label
LY3499446 Phase 1 Cohort A-2 (Low Dose)
regimen
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0004
arm key
OG000
arm label
LY3499446 and Abemaciclib Phase 1
regimen
LY3499446 in combination with abemaciclib orally.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
outcome key
om-0005
arm key
OG000
arm label
LY3499446 and Cetuximab Phase 1
regimen
LY3499446 in combination with cetuximab intravenously (IV).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04165031-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04165031
harm key
EG000
source section id
NCT04165031-ae
event group key
EG000
event group label
LY3499446 Phase 1 Cohort A1 (High Dose)
serious affected
0
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Baseline up to 11 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-lumakras-1056c141
nct id
NCT04165031
harm key
EG001
source section id
NCT04165031-ae
event group key
EG001
event group label
LY3499446 Phase 1 Cohort AO (Mid Dose)
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
Baseline up to 11 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-lumakras-1056c141
nct id
NCT04165031
harm key
EG002
source section id
NCT04165031-ae
event group key
EG002
event group label
LY3499446 Phase 1 Cohort A-2 (Low Dose)
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Baseline up to 11 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