Trial · NCT02186847
Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
NCT02186847, Phase 2, Completed, NRG Oncology; results first posted 2020-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer. Trials, record NCT02186847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02186847
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
- NCT number
- NCT02186847
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 170 participants, actual
- Lead sponsor
- NRG Oncology
- Conditions
Adenosquamous Lung Carcinoma, Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma, Lung Adenocarcinoma, Non-Small Cell Lung Carcinoma, Recurrent Non-Small Cell Lung Carcinoma, Squamous Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer
- Interventions
- Radiation Therapy, Carboplatin, Metformin, Paclitaxel
- First posted
- 2014-07-10
- Last updated
- 2026-07-13
- Results first posted
- 2020-06-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Alive Without Progression (Progression-free Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | 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. |
| Secondary | Percentage of Participants Alive (Overall Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | 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. |
| Secondary | Percentage of Participants With Local-regional Progression | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | 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. |
| Secondary | Percentage of Participants With Distant Metastases | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | 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. |
| Secondary | Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Alive Without Progression (Progression-free Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive (Overall Survival) | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local-regional Progression | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Distant Metastases | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | Eligible participants who started protocol treatment | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Alive Without Progression (Progression-free Survival) | Chemoradiation | 60.4 | 95% Confidence Interval 48.5 to 70.4 | percentage of participants | |
| Percentage of Participants Alive Without Progression (Progression-free Survival) | Metformin + Chemoradiation | 51.3 | 95% Confidence Interval 39.8 to 61.7 | percentage of participants | |
| Percentage of Participants Alive (Overall Survival) | Chemoradiation | 38.5 | 95% Confidence Interval 26.3 to NA | percentage of participants | |
| Percentage of Participants Alive (Overall Survival) | Metformin + Chemoradiation | 40.1 | 95% Confidence Interval 27.9 to NA | percentage of participants | |
| Percentage of Participants With Local-regional Progression | Chemoradiation | 17.2 | 95% Confidence Interval 9.7 to 26.6 | percentage of participants | |
| Percentage of Participants With Local-regional Progression | Metformin + Chemoradiation | 20.5 | 95% Confidence Interval 12.4 to 30.2 | percentage of participants | |
| Percentage of Participants With Distant Metastases | Chemoradiation | 17.2 | 95% Confidence Interval 9.7 to 26.6 | percentage of participants | |
| Percentage of Participants With Distant Metastases | Metformin + Chemoradiation | 20.5 | 95% Confidence Interval 12.4 to 30.2 | percentage of participants | |
| Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | Chemoradiation | 67.1 | 95% Confidence Interval 55.4 to 77.5 | percentage of participants | |
| Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | Metformin + Chemoradiation | 63.4 | 95% Confidence Interval 52.1 to 73.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiation | 84 | |
| Overall Study | STARTED | Metformin + Chemoradiation | 86 | |
| Overall Study | Eligible Population | Chemoradiation | 81 | |
| Overall Study | Eligible Population | Metformin + Chemoradiation | 86 | |
| Overall Study | Eligible and Started Protocol Treatment | Chemoradiation | 76 | |
| Overall Study | Eligible and Started Protocol Treatment | Metformin + Chemoradiation | 82 | |
| Overall Study | COMPLETED | Chemoradiation | 81 | |
| Overall Study | COMPLETED | Metformin + Chemoradiation | 86 | |
| Overall Study | NOT COMPLETED | Chemoradiation | 3 | |
| Overall Study | NOT COMPLETED | Metformin + Chemoradiation | 0 |
Source ClinicalTrials.gov
Adverse events306
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Chemoradiation | 50 | 76 | |
| other | Anemia | Blood and lymphatic system disorders | Metformin + Chemoradiation | 46 | 82 | |
| other | Atrial fibrillation | Cardiac disorders | Chemoradiation | 2 | 76 | |
| other | Atrial fibrillation | Cardiac disorders | Metformin + Chemoradiation | 5 | 82 | |
| other | Sinus tachycardia | Cardiac disorders | Chemoradiation | 3 | 76 | |
| other | Sinus tachycardia | Cardiac disorders | Metformin + Chemoradiation | 7 | 82 | |
| other | Hearing impaired | Ear and labyrinth disorders | Chemoradiation | 5 | 76 | |
| other | Hearing impaired | Ear and labyrinth disorders | Metformin + Chemoradiation | 1 | 82 | |
| other | Blurred vision | Eye disorders | Chemoradiation | 4 | 76 | |
| other | Blurred vision | Eye disorders | Metformin + Chemoradiation | 4 | 82 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoradiation | 31 | 76 |
| Total, all-cause mortality | Metformin + Chemoradiation | 34 | 82 |
| Total, other adverse events | Chemoradiation | 75 | 76 |
| Total, other adverse events | Metformin + Chemoradiation | 79 | 82 |
| Total, serious adverse events | Chemoradiation | 31 | 76 |
| Total, serious adverse events | Metformin + Chemoradiation | 27 | 82 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34323922 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemoradiation vs Metformin + Chemoradiation: deaths from any cause | Trial comparisons |
| Chemoradiation vs Metformin + Chemoradiation: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02186847
GET https://conductscience.org/api/trials/v1/NCT02186847/events?page=2