Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

Draft scope assessment: unclear. Attached because the study's own record names EGFR and names EGFR. The study record does not state Exon 19 Deletion, so it may describe a different alteration of the same gene. 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

Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Full Analysis Set (FAS)-including all subjects who received at least one dose of capmatinib

→

secondary · POSTED

Time from the date of the first documented CR or PR by BIRC per RECIST 1.1 to the first documented progression or date of death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Participants with confirmed CR or PR by BIRC in FAS

→

secondary · POSTED

Percentage of patients with a best overall response defined as confirmed CR or PR per RECIST 1.1 by investigator assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

FAS, including all subjects who received at least one dose of capmatinib.

→

secondary · POSTED

Time from the date of the first documented CR or PR per RECIST 1.1 by investigator assessment to the first documented progression or death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Participants with confirmed CR or PR by investigator assessment in FAS.

→

secondary · POSTED

Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by BIRC assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Participants with confirmed CR or PR by BIRC in FAS

→

secondary · POSTED

Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by investigator assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Participants with confirmed CR or PR by investigator assessment in FAS

→

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-rybrevant-faspro-964accb6
nct id: NCT02414139
trial label: Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)
applicability: unclear
applicability note: Attached because the study's own record names EGFR and names EGFR. The study record does not state Exon 19 Deletion, so it may describe a different alteration of the same gene. 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: 26
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
source section id
NCT02414139-om-0000
source outcome index
0
endpoint
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) Assessment
endpoint definition
Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
time origin
Up to approximately 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS)-including all subjects who received at least one dose of capmatinib
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-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0001
source section id
NCT02414139-om-0001
source outcome index
1
endpoint
Duration of Response (DOR) by BIRC Assessment
endpoint definition
Time from the date of the first documented CR or PR by BIRC per RECIST 1.1 to the first documented progression or date of death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
time origin
Up to approximately 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with confirmed CR or PR by BIRC in FAS
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-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0002
source section id
NCT02414139-om-0002
source outcome index
2
endpoint
ORR by Investigator Assessment
endpoint definition
Percentage of patients with a best overall response defined as confirmed CR or PR per RECIST 1.1 by investigator assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
time origin
Up to approximately 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS, including all subjects who received at least one dose of capmatinib.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0003
source section id
NCT02414139-om-0003
source outcome index
3
endpoint
DOR by Investigator Assessment
endpoint definition
Time from the date of the first documented CR or PR per RECIST 1.1 by investigator assessment to the first documented progression or death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
time origin
Up to approximately 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with confirmed CR or PR by investigator assessment in FAS.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0004
source section id
NCT02414139-om-0004
source outcome index
4
endpoint
Time to Response (TTR) by BIRC Assessment
endpoint definition
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by BIRC assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
time origin
Up to approximately 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with confirmed CR or PR by BIRC in FAS
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-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0005
source section id
NCT02414139-om-0005
source outcome index
5
endpoint
TTR by Investigator Assessment
endpoint definition
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by investigator assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
time origin
Up to approximately 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with confirmed CR or PR by investigator assessment in FAS
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-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG000
arm label
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
regimen
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG001
arm label
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
regimen
Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG002
arm label
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
regimen
Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG003
arm label
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
regimen
Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG004
arm label
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
regimen
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG005
arm label
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
regimen
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG006
arm label
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
regimen
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG007
arm label
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
regimen
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG008
arm label
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
regimen
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG009
arm label
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
regimen
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG010
arm label
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
regimen
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
outcome key
om-0000
arm key
OG011
arm label
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
regimen
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02414139-om-0000#groups/OG011

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG000
source section id
NCT02414139-ae
event group key
EG000
event group label
Cohort 1a: On-treatment
serious affected
42
serious at risk
69
other affected
66
other at risk
69
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG001
source section id
NCT02414139-ae
event group key
EG001
event group label
Cohort 1b: On-treatment
serious affected
21
serious at risk
42
other affected
41
other at risk
42
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG002
source section id
NCT02414139-ae
event group key
EG002
event group label
Cohort 2: On-treatment
serious affected
30
serious at risk
54
other affected
53
other at risk
54
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG003
source section id
NCT02414139-ae
event group key
EG003
event group label
Cohort 3: On-treatment
serious affected
15
serious at risk
30
other affected
28
other at risk
30
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG004
source section id
NCT02414139-ae
event group key
EG004
event group label
Cohort 4: On-treatment
serious affected
38
serious at risk
69
other affected
66
other at risk
69
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG005
source section id
NCT02414139-ae
event group key
EG005
event group label
Cohort 5a: On-treatment
serious affected
9
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG006
source section id
NCT02414139-ae
event group key
EG006
event group label
Cohort 5b: On-treatment
serious affected
14
serious at risk
28
other affected
28
other at risk
28
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG007
source section id
NCT02414139-ae
event group key
EG007
event group label
Cohort 6.1 (Expansion of Cohort 1a): On-treatment
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG008
source section id
NCT02414139-ae
event group key
EG008
event group label
Cohort 6.2 (Expansion of Cohort 4): On-treatment
serious affected
14
serious at risk
31
other affected
29
other at risk
31
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG009
source section id
NCT02414139-ae
event group key
EG009
event group label
Cohort 7 (Expansion of Cohort 5b): On-treatment
serious affected
17
serious at risk
32
other affected
31
other at risk
32
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG010
source section id
NCT02414139-ae
event group key
EG010
event group label
Cohort 4 + Cohort 6.2: On-treatment
serious affected
52
serious at risk
100
other affected
95
other at risk
100
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
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-rybrevant-faspro-964accb6
nct id
NCT02414139
harm key
EG011
source section id
NCT02414139-ae
event group key
EG011
event group label
Cohort 5b + Cohort 7: On-treatment
serious affected
31
serious at risk
60
other affected
59
other at risk
60
frequency threshold
5
collection period
Adverse events (AEs) were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approximately 5.5 years. Deaths were collected in the post treatment efficacy/survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 6 years.
event definition
Deaths in the post-treatment efficacy/survival follow-up are not counted as AEs. The total number at risk in the post-treatment efficacy/survival includes patients who entered the post-treatment efficacy and/or survival follow-up periods.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice