TriangleNCT02186847 · STUDY IN CONTEXT
Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. 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 per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: \[1\] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of ≥1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Local-regional progression (LRP) is defined as progression within the planned treatment volume (PTV) or outside the PTV but within the same lobe(s) of the lung as the primary tumor or in regional lymph nodes. Progression is defined as change in a known lesion(s) meeting one of the following criteria: \[1\] ≥ 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of ≥1 new lesions. LRP time is defined as time from randomization to the date of first LRP, death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 LRP events were reported.
Distant metastasis (DM) is defined as the appearance of ≥ 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Adverse events (AE) were 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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- trial label
- Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes locally advanced disease. 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
- 5
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0000
- source section id
- NCT02186847-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Alive Without Progression (Progression-free Survival)
- endpoint definition
- Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: \[1\] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of ≥1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants
- 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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0001
- source section id
- NCT02186847-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants Alive (Overall Survival)
- endpoint definition
- Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants
- 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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0002
- source section id
- NCT02186847-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Local-regional Progression
- endpoint definition
- Local-regional progression (LRP) is defined as progression within the planned treatment volume (PTV) or outside the PTV but within the same lobe(s) of the lung as the primary tumor or in regional lymph nodes. Progression is defined as change in a known lesion(s) meeting one of the following criteria: \[1\] ≥ 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be \> 5 mm. \[2\] Appearance of ≥1 new lesions. LRP time is defined as time from randomization to the date of first LRP, death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 LRP events were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants
- 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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0003
- source section id
- NCT02186847-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants With Distant Metastases
- endpoint definition
- Distant metastasis (DM) is defined as the appearance of ≥ 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants
- 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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0004
- source section id
- NCT02186847-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
- endpoint definition
- Adverse events (AE) were 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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
- time origin
- From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants who started protocol treatment
- 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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Chemoradiation
- regimen
- 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Metformin + Chemoradiation
- regimen
- Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 86
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Chemoradiation
- regimen
- 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Metformin + Chemoradiation
- regimen
- Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 86
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Chemoradiation
- regimen
- 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Metformin + Chemoradiation
- regimen
- Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 86
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Chemoradiation
- regimen
- 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Metformin + Chemoradiation
- regimen
- Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 86
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Chemoradiation
- regimen
- 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 76
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Metformin + Chemoradiation
- regimen
- Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
- analyzed count
- 82
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186847-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- harm key
- EG000
- source section id
- NCT02186847-ae
- event group key
- EG000
- event group label
- Chemoradiation
- serious affected
- 31
- serious at risk
- 76
- other affected
- 75
- other at risk
- 76
- frequency threshold
- 5
- collection period
- Adverse events were to be reported weekly during dose escalation on metformin arm, end of chemoradiation, end of post-radiation chemotherapy/metformin, 4-6 weeks follow-up, every 3 months for 2 years follow-up, every 6 months through 5 years follow-up, yearly until study termination completion.
- event definition
- Source null
- 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-squamous-cell-carcinoma-docivyx-1bcd0a29
- nct id
- NCT02186847
- harm key
- EG001
- source section id
- NCT02186847-ae
- event group key
- EG001
- event group label
- Metformin + Chemoradiation
- serious affected
- 27
- serious at risk
- 82
- other affected
- 79
- other at risk
- 82
- frequency threshold
- 5
- collection period
- Adverse events were to be reported weekly during dose escalation on metformin arm, end of chemoradiation, end of post-radiation chemotherapy/metformin, 4-6 weeks follow-up, every 3 months for 2 years follow-up, every 6 months through 5 years follow-up, yearly until study termination completion.
- event definition
- Source null
- 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