Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

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

Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.

Eligible patients

→

secondary · POSTED

Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.

Eligible patients with disease assessment

→

secondary · POSTED

Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Eligible patients who started study treatment

→

secondary · POSTED

Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Eligible patients

→

secondary · POSTED

Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.

Eligible patients

→

secondary · POSTED

Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.

Eligible patients

→

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-emrelis-64185771
nct id: NCT01822496
trial label: Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
applicability: unclear
applicability note: Attached because the study's own record names MET. 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: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0000
source section id
NCT01822496-om-0000
source outcome index
0
endpoint
Progression-free Survival
endpoint definition
Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.
time origin
From randomization to study termination. Maximum follow-up was 39.0 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients
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-emrelis-64185771
nct id
NCT01822496
outcome key
om-0001
source section id
NCT01822496-om-0001
source outcome index
1
endpoint
Percentage of Patients With Complete or Partial Response
endpoint definition
Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.
time origin
From randomization to study termination. Maximum follow-up was 39.0 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with disease 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-emrelis-64185771
nct id
NCT01822496
outcome key
om-0002
source section id
NCT01822496-om-0002
source outcome index
2
endpoint
Number of Patients With Grade 3-5 Adverse Events
endpoint definition
Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
time origin
From randomization to study termination. Maximum follow-up was 39.0 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who started study treatment
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-emrelis-64185771
nct id
NCT01822496
outcome key
om-0003
source section id
NCT01822496-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
time origin
From randomization to study termination. Maximum follow-up was 39.0 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients
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-emrelis-64185771
nct id
NCT01822496
outcome key
om-0004
source section id
NCT01822496-om-0004
source outcome index
4
endpoint
Local-regional Progression-free Survival
endpoint definition
Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
time origin
From randomization to study termination. Maximum follow-up was 39.0 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients
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-emrelis-64185771
nct id
NCT01822496
outcome key
om-0005
source section id
NCT01822496-om-0005
source outcome index
5
endpoint
Distant Progression-free Survival
endpoint definition
Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
time origin
From randomization to study termination. Maximum follow-up was 39.0 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients
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-emrelis-64185771
nct id
NCT01822496
outcome key
om-0000
arm key
OG000
arm label
EGFR: Erlotinib
regimen
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0000
arm key
OG001
arm label
EGFR: No Erlotinib
regimen
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0000
arm key
OG002
arm label
ALK: Crizotinib
regimen
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0000
arm key
OG003
arm label
ALK: No Crizotinib
regimen
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0001
arm key
OG000
arm label
EGFR: Erlotinib
regimen
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0001
arm key
OG001
arm label
EGFR: No Erlotinib
regimen
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0001
arm key
OG002
arm label
ALK: Crizotinib
regimen
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0001
arm key
OG003
arm label
ALK: No Crizotinib
regimen
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0002
arm key
OG000
arm label
EGFR: Erlotinib
regimen
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0002
arm key
OG001
arm label
EGFR: No Erlotinib
regimen
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0002
arm key
OG002
arm label
ALK: Crizotinib
regimen
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
outcome key
om-0002
arm key
OG003
arm label
ALK: No Crizotinib
regimen
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01822496-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT01822496
harm key
EG000
source section id
NCT01822496-ae
event group key
EG000
event group label
EGFR: Erlotinib
serious affected
1
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
From randomization to last follow-up. Maximum follow-up was 39.0 months.
event definition
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
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-emrelis-64185771
nct id
NCT01822496
harm key
EG001
source section id
NCT01822496-ae
event group key
EG001
event group label
EGFR: No Erlotinib
serious affected
7
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
collection period
From randomization to last follow-up. Maximum follow-up was 39.0 months.
event definition
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
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-emrelis-64185771
nct id
NCT01822496
harm key
EG002
source section id
NCT01822496-ae
event group key
EG002
event group label
ALK: Crizotinib
serious affected
4
serious at risk
9
other affected
8
other at risk
9
frequency threshold
5
collection period
From randomization to last follow-up. Maximum follow-up was 39.0 months.
event definition
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
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-emrelis-64185771
nct id
NCT01822496
harm key
EG003
source section id
NCT01822496-ae
event group key
EG003
event group label
ALK: No Crizotinib
serious affected
2
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
From randomization to last follow-up. Maximum follow-up was 39.0 months.
event definition
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
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