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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02186847
Recruitment Status : Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

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.

Condition or disease Intervention/treatment Phase
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 Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Carboplatin Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Drug: Metformin Hydrochloride Drug: Paclitaxel Radiation: Volume Modulated Arc Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and undergo radiation therapy (3-dimensional conformal radiation therapy [3D-CRT] or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy comprising paclitaxel IV and carboplatin IV on days 1 and 22. Treatment with consolidation chemotherapy repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) or thrice daily (TID) for 14 days. Beginning on day 15, patients undergo radiation therapy and receive paclitaxel and carboplatin as in Arm I, and receive metformin hydrochloride BID or TID for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy as in Arm I and metformin hydrochloride PO BID or TID for 10 weeks.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
Study Start Date : August 2014
Actual Primary Completion Date : April 16, 2019
Estimated Study Completion Date : April 16, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm I (chemoradiotherapy)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and undergo radiation therapy (3D-CRT or IMRT) QD 5 days a week for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy comprising paclitaxel IV and carboplatin IV on days 1 and 22. Treatment with consolidation chemotherapy repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo radiation therapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplat
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Radiation: Intensity-Modulated Radiation Therapy
Undergo radiation therapy
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Radiation: Volume Modulated Arc Therapy
Undergo radiation therapy
Other Name: VMAT

Experimental: Arm II (chemoradiotherapy, metformin hydrochloride)
Patients receive metformin hydrochloride PO BID or TID for 14 days. Beginning on day 15, patients undergo radiation therapy and receive paclitaxel and carboplatin as in Arm I and receive metformin hydrochloride BID or TID for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy as in Arm I and metformin hydrochloride PO BID or TID for 10 weeks.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo radiation therapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplat
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Radiation: Intensity-Modulated Radiation Therapy
Undergo radiation therapy
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Metformin Hydrochloride
Given PO
Other Names:
  • Glucophage
  • Metformin HCl

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Radiation: Volume Modulated Arc Therapy
Undergo radiation therapy
Other Name: VMAT




Primary Outcome Measures :
  1. PFS [ Time Frame: Interval from randomization to progression or death due to any cause, whichever occurs first, assessed up to 5 years ]
    PFS rates will be estimated using the Kaplan-Meier method, and the differences between arms will be tested using a log-rank test. A multivariate analysis with the Cox proportional hazard model for PFS will be performed with the stratification variables as fixed variables to assess the treatment effect adjusting for patient-specific risk factors.


Secondary Outcome Measures :
  1. OS [ Time Frame: Interval from randomization to death due to any cause, assessed up to 5 years ]
    OS is analyzed as time-to-event data, where the OS rates will be estimated using the Kaplan-Meier method, and the differences between treatment arms will be tested using the log-rank test.

  2. Rate of treatment-related adverse events using National Cancer Institution (NCI) CTCAE, v. 4 [ Time Frame: Within 1 year of completion of all treatment ]
    Will be reported with the frequency and severity (e.g., type, grade, and attribution) by arm, and analyzed using Chi-square test or Fisher's exact test wherever applicable. The analysis will be performed at the time of primary endpoint analysis. Logistic regression will be used to model the distribution of adverse events with and without adjustment for covariates. Both unadjusted and adjusted odds ratios and the respective 95% confidence intervals will be computed and tested at a significance level of 0.05 (2-sided).

  3. Time to DM [ Time Frame: Interval from randomization to distant metastasis, assessed up to 5 years ]
    Only distant metastasis will be counted as events, and deaths or local-regional progression without distant metastasis will be treated as competing risks. A cumulative incidence approach will be used to estimate the respective rates, and the corresponding differences in LRP and DM will be evaluated using Gray's test.

  4. Time to LRP [ Time Frame: Interval from randomization to local or regional progression, assessed up to 5 years ]
    A competing risks analysis approach will be used when analyzing time to LRP. Only local-regional progression will be counted as events (failures), and patients who die or have a distant metastasis without a local-regional progression will be treated as competing risk. A cumulative incidence approach will be used to estimate the respective rates, and the corresponding differences in LRP and DM will be evaluated using Gray's test.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 [NOS])
  • 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 [BSA], 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 F 18 (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
  • 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)
  • Serum creatinine within normal institutional limits or creatinine clearance must be at least 60 ml/min
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for the institution
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN for the institution
  • 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
  • Patient must provide study specific informed consent prior to study entry

Exclusion Criteria:

  • 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186847


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Locations
Layout table for location information
United States, Alabama
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Memorial Medical Center
Modesto, California, United States, 95355
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States, 95670
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
South Sacramento Cancer Center
Sacramento, California, United States, 95823
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Swedish Medical Center
Englewood, Colorado, United States, 80113
North Colorado Medical Center
Greeley, Colorado, United States, 80631
McKee Medical Center
Loveland, Colorado, United States, 80539
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
21st Century Oncology-Palatka
Palatka, Florida, United States, 32177
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii, United States, 96701
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
IU Health Bloomington
Bloomington, Indiana, United States, 47403
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
United States, Iowa
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Hardin Memorial Hospital
Elizabethtown, Kentucky, United States, 42701
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
United States, Louisiana
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, United States, 70809
Mary Bird Perkins Cancer Center - Covington
Covington, Louisiana, United States, 70433
Mary Bird Perkins Cancer Center - Houma
Houma, Louisiana, United States, 70360
United States, Maine
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
UM Upper Chesapeake Medical Center
Bel Air, Maryland, United States, 21014
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, United States, 21061
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Cancer Institute-Flint
Flint, Michigan, United States, 48532
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, United States, 48446
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States, 48043
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, United States, 48858
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
McLaren Cancer Institute-Owosso
Owosso, Michigan, United States, 48867
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States, 49770
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States, 49085
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
The University of Kansas Cancer Center-South
Kansas City, Missouri, United States, 64131
The University of Kansas Cancer Center-North
Kansas City, Missouri, United States, 64154
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Wentworth-Douglass Hospital
Dover, New Hampshire, United States, 03820
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Community Medical Center
Toms River, New Jersey, United States, 08755
Virtua Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
United States, New York
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Gaston Hematology and Oncology Associates-Belmont
Belmont, North Carolina, United States, 28012
CaroMont Regional Medical Center
Gastonia, North Carolina, United States, 28054
Gaston Hematology and Oncology Associates
Gastonia, North Carolina, United States, 28054
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Mercy Medical Center
Canton, Ohio, United States, 44708
Aultman Health Foundation
Canton, Ohio, United States, 44710
Geauga Hospital
Chardon, Ohio, United States, 44024
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Kettering Medical Center
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States, 44060
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, United States, 44130
Newark Radiation Oncology
Newark, Ohio, United States, 43055
University Hospitals Parma Medical Center
Parma, Ohio, United States, 44129
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States, 44136
University Pointe
West Chester, Ohio, United States, 45069
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States, 44691
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
The Regional Cancer Center
Erie, Pennsylvania, United States, 16505
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center
Houston, Texas, United States, 77030
The Methodist Hospital System
Houston, Texas, United States, 77030
MD Anderson in Katy
Houston, Texas, United States, 77094
UTMB Cancer Center at Victory Lakes
League City, Texas, United States, 77573
MD Anderson League City
Nassau Bay, Texas, United States, 77058
MD Anderson in Sugar Land
Sugar Land, Texas, United States, 77478
MD Anderson in The Woodlands
The Woodlands, Texas, United States, 77384
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, United States, 22939
United States, Washington
Harrison Medical Center
Bremerton, Washington, United States, 98310
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, United States, 53097
Ascension Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States, 53211
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, United States, 53295
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin, United States, 53095
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Theodoros Tsakiridis NRG Oncology

Layout table for additonal information
Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02186847     History of Changes
Other Study ID Numbers: NRG-LU001
NCI-2014-01071 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PNRG-LU001_A01PAMDREVW01
NRG-LU001 ( Other Identifier: NRG Oncology )
NRG-LU001 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma of Lung
Adenocarcinoma, Bronchiolo-Alveolar
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Metformin
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs