AzTrials
AzTrials

Adenosquamous Lung CarcinomaPhase 2NCT02186847

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer

A Phase 2 study testing Radiation Therapy, Carboplatin and Metformin in people with Adenosquamous Lung Carcinoma and Bronchioloalveolar Carcinoma, run by NRG Oncology at 223 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation Therapy, Carboplatin and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
223 sitesin 3 countries
Study dates
Aug 2014to 4 Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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;
  • Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 x ULN for the institution;
  • Fasting blood glucose ≤ 125 mg/dL within 14 days prior to registration;
  • Serum albumin > 3.0 g/dl within 14 days prior to registration;
  • For women of childbearing potential, a serum pregnancy test within 72 hours prior to registration;
  • Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration;
  • Patients must be at least 3 weeks from prior thoracotomy (if performed);
  • If a pleural effusion is present, the following criteria must be met at registration to exclude malignant involvement (incurable M1a disease):
  • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative;
  • Effusions that are minimal (i.e. not visible under ultrasound guidance) and that are too small to safely tap are eligible.
  • Women of childbearing potential and male participants must practice adequate contraception throughout the study;

Who cannot join

  • 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
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  • 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
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
  • End-stage renal disease (ie, on dialysis or dialysis has been recommended)
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Trial locations and contacts

223 sites in 3 countries.

223 sites in 3 countries

United States219 sites

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Gaston Hematology and Oncology Associates-Belmont

    Belmont, North Carolina, 28012

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • IU Health Bloomington

    Bloomington, Indiana, 47408

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Geauga Hospital

    Chardon, Ohio, 44024

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Gaston Hematology and Oncology Associates

    Gastonia, North Carolina, 28054

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Mary Bird Perkins Cancer Center - Houma

    Houma, Louisiana, 70360

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • The University of Kansas Cancer Center-South

    Kansas City, Missouri, 64131

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan, 48446

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • UT MD Anderson - League City

    League City, Texas, 77573

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Ascension Columbia Saint Mary's Hospital Ozaukee

    Mequon, Wisconsin, 53097

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Ascension Columbia Saint Mary's Hospital - Milwaukee

    Milwaukee, Wisconsin, 53211

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59804

  • Memorial Medical Center

    Modesto, California, 95355

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • McLaren Cancer Institute-Central Michigan

    Mount Pleasant, Michigan, 48858

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • McLaren Cancer Institute-Owosso

    Owosso, Michigan, 48867

  • Cancer Center of Putnam

    Palatka, Florida, 32177

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • McLaren Cancer Institute-Northern Michigan

    Petoskey, Michigan, 49770

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • University of Rochester

    Rochester, New York, 14642

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • South Sacramento Cancer Center

    Sacramento, California, 95823

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • TidalHealth Peninsula Regional

    Salisbury, Maryland, 21801

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • UH Seidman Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Joseph Medical Center Hematology and Oncology - Silverdale

    Silverdale, Washington, 98383

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • Lewis and Faye Manderson Cancer Center

    Tuscaloosa, Alabama, 35401

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Intermountain Health Lutheran Hospital

    Wheat Ridge, Colorado, 80401

  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

Canada3 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

Israel1 site

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

About this study

Official title: Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether metformin hydrochloride (MET) added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

  1. Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM).

II. Evaluate the effect of MET on chemoradiotherapy toxicity (Common Terminology Criteria for Adverse Events, version 4 [CTCAE, v. 4]) within 1 year of completion of all treatment.

III. Collect biospecimens to develop biomarkers of MET activity.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Being tested
Radiation Therapy, Carboplatin, Metformin, Paclitaxel
Medical subject headings
Adenocarcinoma, Bronchiolo-Alveolar, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyRadiation

    Also called 3-dimensional conformal radiation therapy, 3D-CRT, Intensity-modulated radiation therapy, IMRT

    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).

  • CarboplatinDrug

    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.

  • MetforminDrug

    Also called Metformin HCL, Metformin Hydrochloride

    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),

  • PaclitaxelDrug

    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.

Study groups in NCT02186847
Study groupRoleWhat they receive
ChemoradiationActive comparator60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Receives: Radiation: Radiation Therapy; Drug: Carboplatin; Drug: Paclitaxel
Metformin + ChemoradiationExperimentalMetformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Receives: Radiation: Radiation Therapy; Drug: Carboplatin; Drug: Metformin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

Secondary outcomes (4)

  1. Percentage of Participants Alive (Overall Survival)

    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.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

  2. Percentage of Participants With Local-regional Progression

    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.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

  3. Percentage of Participants With Distant Metastases

    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.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

  4. Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events

    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.

    Measured: From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion16 Apr 2019
  4. Study completion4 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186847
Sponsor's protocol ID
NRG-LU001
Other IDs
NCI-2014-01071, PNRG-LU001_A01PAMDREVW01, NRG-LU001, NRG-LU001, U10CA180868
Status last verified
Jun 2026
First submitted
8 Jul 2014
Last updated
13 Jul 2026
Data monitoring committee
Yes
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • 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.

    PubMed 34323922

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy, Carboplatin and Metformin in people with Adenosquamous Lung Carcinoma and Bronchioloalveolar Carcinoma, run by NRG Oncology at 223 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States, Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Alive Without Progression (Progression-free Survival) (time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186847, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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