Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

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

Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.

A total of 6 participants were treated with erlotinib on study.

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secondary · POSTED

The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.

A total of 42 participants had plasma genotyping results available (1 of the 43 enrolled participants did not have plasma genotyping).

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secondary · POSTED

Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping

35 of the 42 participants with plasma genotyping results also had tumor genotyping results available, so PPV and false negative rate could be assessed in these 35 participants.

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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-lazcluze-6be86311
nct id: NCT02770014
trial label: Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer
applicability: unclear
applicability note: Attached because the study's own record names EGFR. 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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lazcluze-6be86311
nct id
NCT02770014
outcome key
om-0000
source section id
NCT02770014-om-0000
source outcome index
0
endpoint
Overall Response Rate
endpoint definition
Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.
time origin
From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
A total of 6 participants were treated with erlotinib on 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-lazcluze-6be86311
nct id
NCT02770014
outcome key
om-0001
source section id
NCT02770014-om-0001
source outcome index
1
endpoint
Turnaround Time
endpoint definition
The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.
time origin
Maximum 38 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
A total of 42 participants had plasma genotyping results available (1 of the 43 enrolled participants did not have plasma genotyping).
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-lazcluze-6be86311
nct id
NCT02770014
outcome key
om-0002
source section id
NCT02770014-om-0002
source outcome index
2
endpoint
Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
endpoint definition
Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping
time origin
PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
35 of the 42 participants with plasma genotyping results also had tumor genotyping results available, so PPV and false negative rate could be assessed in these 35 participants.
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-lazcluze-6be86311
nct id
NCT02770014
outcome key
om-0000
arm key
OG000
arm label
EGFR Exon 19 Positive Treatment With Erlotinib
regimen
Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02770014-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lazcluze-6be86311
nct id
NCT02770014
outcome key
om-0001
arm key
OG000
arm label
Participants With Plasma Genotyping
regimen
Participants who enrolled to the study and had plasma genotyping
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02770014-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lazcluze-6be86311
nct id
NCT02770014
outcome key
om-0002
arm key
OG000
arm label
Participants With Plasma Genotyping
regimen
Participants who enrolled to the study and had plasma genotyping
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02770014-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lazcluze-6be86311
nct id
NCT02770014
harm key
EG000
source section id
NCT02770014-ae
event group key
EG000
event group label
EGFR Exon 19 Positive Treatment With Erlotinib
serious affected
0
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
event definition
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
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