TriangleNCT01822496 · STUDY IN CONTEXT
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
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.
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.
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.
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.
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.
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.
Reported safety
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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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-tepmetko-e2d8dca4
- 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