Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
4 other identifiers
interventional
170
3 countries
224
Brief Summary
This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2014
Longer than P75 for phase_2
224 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2019
CompletedResults Posted
Study results publicly available
June 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2025
CompletedOctober 9, 2025
September 1, 2025
4.7 years
July 8, 2014
May 18, 2020
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Alive Without Progression (Progression-free Survival)
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.
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Secondary Outcomes (4)
Percentage of Participants Alive (Overall Survival)
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Percentage of Participants With Local-regional Progression
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Percentage of Participants With Distant Metastases
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
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.
Study Arms (2)
Chemoradiation
ACTIVE COMPARATOR60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Metformin + Chemoradiation
EXPERIMENTALMetformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Interventions
Radiation therapy (RT) is given in 2 Gy fractions once daily 5 days per week to a total of 30 fractions and 60 Gy. Photons required; 3-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) permitted. Starts within 14 days of randomization (Chemoradiation arm) or 14 days after metformin starts (Chemoradiation + Metformin arm).
2 AUC (area under the curve) via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 6 AUC via IV starting 28-42 days after the end of radiation therapy.
Metformin is taken orally. Dose escalation begins 2 weeks prior to the initiation of chemoradiation. 500 mg twice daily days 1-7 of metformin. 500 mg three times daily days 8-14 of metformin. Three times a day with the following dosage: 500mg in the morning, 1000mg at noon, and 500mg in the evening concurrent with chemoradiation and through consolidation chemotherapy (days 15-126 of metformin),
50 mg/m2 via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 200 mg/m2 via IV 28-42 days after the end of radiation therapy.
Eligibility Criteria
You may qualify if:
- Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified)
- Patients must have measurable disease
- Patients must have unresectable disease, be medically inoperable, or unwilling to undergo surgical management
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including documentation of height, weight, body surface area, and vital signs, within 30 days prior to registration
- Computed tomography (CT) with IV contrast or magnetic resonance imaging (MRI) imaging (if CT scan with contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands, required within 45 days prior to registration (recommended within 30 days prior to registration
- MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 45 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT; an MRI without contrast is only permitted if the patient has a contrast allergy
- Whole-body fludeoxyglucose (FDG)-positron emission tomography (PET)/CT required within 45 days prior to registration (recommended within 30 days prior to registration; note: patients do not need to have a separate CT of the chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT with contrast
- Zubrod performance status 0-1
- Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
- Complete blood count(CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets \>= 100,000 cells/mm\^3
- Hemoglobin \>= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
- Adequate renal function within 14 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance must be at least 60 ml/min;
- +10 more criteria
You may not qualify if:
- Patients with mixed small cell and non-small cell histologies
- Patients with distant metastasis
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Patients currently using metformin (metformin hydrochloride), other oral hypoglycemic agents or insulin
- Patients with any history of allergic reaction to paclitaxel or other taxanes or carboplatin
- Patients with a history of chronic kidney disease or lactic acidosis
- Patients with \>= 10% weight loss within the past month
- Severe, active co-morbidity, defined as follows:
- Diagnosis of type I or type II diabetes mellitus
- Uncontrolled neuropathy \>= grade 2 regardless of cause
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (224)
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
21st Century Oncology-Palatka
Palatka, Florida, 32177, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, 83301, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
IU Health Bloomington
Bloomington, Indiana, 47403, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Hardin Memorial Hospital
Elizabethtown, Kentucky, 42701, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center - Covington
Covington, Louisiana, 70433, United States
Mary Bird Perkins Cancer Center - Houma
Houma, Louisiana, 70360, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
McLaren Cancer Institute-Owosso
Owosso, Michigan, 48867, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
William Beaumont Hospital - Troy
Troy, Michigan, 48085, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, 64131, United States
The University of Kansas Cancer Center-North
Kansas City, Missouri, 64154, United States
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri, 64064, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
University of Rochester
Rochester, New York, 14642, United States
Gaston Hematology and Oncology Associates-Belmont
Belmont, North Carolina, 28012, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054, United States
Gaston Hematology and Oncology Associates
Gastonia, North Carolina, 28054, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
University Pointe
West Chester, Ohio, 45069, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
The Regional Cancer Center
Erie, Pennsylvania, 16505, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
The Methodist Hospital System
Houston, Texas, 77030, United States
MD Anderson in Katy
Houston, Texas, 77094, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
MD Anderson League City
Nassau Bay, Texas, 77058, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands
The Woodlands, Texas, 77384, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, 05819, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
Harrison Medical Center
Bremerton, Washington, 98310, United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Ascension Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin, 53095, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, 54494, United States
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Related Publications (1)
Skinner H, Hu C, Tsakiridis T, Santana-Davila R, Lu B, Erasmus JJ, Doemer AJ, Videtic GMM, Coster J, Yang AX, Lee RY, Werner-Wasik M, Schaner PE, McCormack SE, Esparaz BT, McGarry RC, Bazan J, Struve T, Paulus R, Bradley JD. Addition of Metformin to Concurrent Chemoradiation in Patients With Locally Advanced Non-Small Cell Lung Cancer: The NRG-LU001 Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1324-1332. doi: 10.1001/jamaoncol.2021.2318.
PMID: 34323922DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Theodoros Tsakiridis
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 10, 2014
Study Start
August 1, 2014
Primary Completion
April 16, 2019
Study Completion
September 4, 2025
Last Updated
October 9, 2025
Results First Posted
June 23, 2020
Record last verified: 2025-09