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

Primary Purpose

Adenosquamous Lung Carcinoma, Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radiation Therapy
Carboplatin
Metformin
Paclitaxel
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenosquamous Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
  • 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;
  • 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;

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

Sites / Locations

  • Lewis and Faye Manderson Cancer Center
  • Banner University Medical Center - Tucson
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  • Eden Hospital Medical Center
  • UC San Diego Moores Cancer Center
  • Memorial Medical Center
  • Kaiser Permanente Oakland-Broadway
  • Kaiser Permanente-Rancho Cordova Cancer Center
  • Rohnert Park Cancer Center
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
  • The Permanente Medical Group-Roseville Radiation Oncology
  • Sutter Medical Center Sacramento
  • South Sacramento Cancer Center
  • UCSF Medical Center-Mount Zion
  • Kaiser Permanente Cancer Treatment Center
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
  • University of Colorado Hospital
  • Penrose-Saint Francis Healthcare
  • UCHealth Memorial Hospital Central
  • Swedish Medical Center
  • North Colorado Medical Center
  • McKee Medical Center
  • SCL Health Lutheran Medical Center
  • Christiana Care Health System-Christiana Hospital
  • UF Cancer Center at Orlando Health
  • 21st Century Oncology-Palatka
  • Piedmont Hospital
  • John B Amos Cancer Center
  • Dekalb Medical Center
  • Memorial Health University Medical Center
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • The Cancer Center of Hawaii-Pali Momi
  • Queen's Medical Center
  • The Cancer Center of Hawaii-Liliha
  • Saint Alphonsus Cancer Care Center-Boise
  • Kootenai Cancer Center
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Northwest Community Hospital
  • John H Stroger Jr Hospital of Cook County
  • Rush University Medical Center
  • Decatur Memorial Hospital
  • Good Samaritan Regional Health Center
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  • Methodist Medical Center of Illinois
  • OSF Saint Francis Medical Center
  • Memorial Medical Center
  • Carle Cancer Center
  • IU Health Bloomington
  • Radiation Oncology Associates PC
  • Parkview Hospital Randallia
  • Franciscan Health Indianapolis
  • Mercy Hospital
  • University of Kansas Cancer Center
  • Lawrence Memorial Hospital
  • University of Kansas Cancer Center-Overland Park
  • Ascension Via Christi Hospitals Wichita
  • Wesley Medical Center
  • Hardin Memorial Hospital
  • Baptist Health Lexington
  • University of Kentucky/Markey Cancer Center
  • LSU Health Baton Rouge-North Clinic
  • Louisiana Hematology Oncology Associates LLC
  • Mary Bird Perkins Cancer Center
  • Our Lady of the Lake Physicians Group - Medical Oncology
  • Mary Bird Perkins Cancer Center - Covington
  • Mary Bird Perkins Cancer Center - Houma
  • Maine Medical Center- Scarborough Campus
  • University of Maryland/Greenebaum Cancer Center
  • UM Upper Chesapeake Medical Center
  • UM Baltimore Washington Medical Center/Tate Cancer Center
  • Peninsula Regional Medical Center
  • Boston Medical Center
  • Lowell General Hospital
  • Henry Ford Hospital
  • McLaren Cancer Institute-Flint
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • West Michigan Cancer Center
  • McLaren Cancer Institute-Lapeer Region
  • McLaren Cancer Institute-Macomb
  • McLaren Cancer Institute-Central Michigan
  • Mercy Health Mercy Campus
  • McLaren Cancer Institute-Owosso
  • McLaren Cancer Institute-Northern Michigan
  • Saint Joseph Mercy Oakland
  • William Beaumont Hospital-Royal Oak
  • Lakeland Medical Center Saint Joseph
  • William Beaumont Hospital - Troy
  • Sanford Joe Lueken Cancer Center
  • Mercy Hospital
  • Saint Luke's Hospital of Duluth
  • Fairview-Southdale Hospital
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • Regions Hospital
  • United Hospital
  • Rice Memorial Hospital
  • University of Mississippi Medical Center
  • Saint Francis Medical Center
  • Southeast Cancer Center
  • North Kansas City Hospital
  • The University of Kansas Cancer Center-South
  • The University of Kansas Cancer Center-North
  • The University of Kansas Cancer Center-Lee's Summit
  • Delbert Day Cancer Institute at PCRMC
  • Missouri Baptist Medical Center
  • Mercy Hospital Saint Louis
  • CoxHealth South Hospital
  • Billings Clinic Cancer Center
  • Community Medical Hospital
  • CHI Health Saint Francis
  • CHI Health Good Samaritan
  • Nebraska Methodist Hospital
  • University of Nebraska Medical Center
  • Wentworth-Douglass Hospital
  • Dartmouth Hitchcock Medical Center
  • Virtua Memorial
  • Community Medical Center
  • Virtua Voorhees
  • University of New Mexico Cancer Center
  • New Mexico Oncology Hematology Consultants
  • New York-Presbyterian/Brooklyn Methodist Hospital
  • University of Rochester
  • Gaston Hematology and Oncology Associates-Belmont
  • CaroMont Regional Medical Center
  • Gaston Hematology and Oncology Associates
  • FirstHealth of the Carolinas-Moore Regional Hospital
  • Sanford Bismarck Medical Center
  • Sanford Roger Maris Cancer Center
  • UHHS-Chagrin Highlands Medical Center
  • Mercy Medical Center
  • Aultman Health Foundation
  • Geauga Hospital
  • Adena Regional Medical Center
  • University of Cincinnati/Barrett Cancer Center
  • Case Western Reserve University
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Ohio State University Comprehensive Cancer Center
  • Riverside Methodist Hospital
  • The Mark H Zangmeister Center
  • Mount Carmel Health Center West
  • Good Samaritan Hospital - Dayton
  • Mercy Cancer Center-Elyria
  • Cleveland Clinic Cancer Center Independence
  • Kettering Medical Center
  • Hillcrest Hospital Cancer Center
  • UH Seidman Cancer Center at Lake Health Mentor Campus
  • UH Seidman Cancer Center at Southwest General Hospital
  • Newark Radiation Oncology
  • University Hospitals Parma Medical Center
  • Southern Ohio Medical Center
  • North Coast Cancer Care
  • UH Seidman Cancer Center at Firelands Regional Medical Center
  • Cleveland Clinic Cancer Center Strongsville
  • University Pointe
  • UHHS-Westlake Medical Center
  • Cleveland Clinic Wooster Family Health and Surgery Center
  • Genesis Healthcare System Cancer Care Center
  • University of Oklahoma Health Sciences Center
  • Abington Memorial Hospital
  • Geisinger Medical Center
  • Northeast Radiation Oncology Center
  • The Regional Cancer Center
  • Thomas Jefferson University Hospital
  • UPMC-Shadyside Hospital
  • Reading Hospital
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Lankenau Medical Center
  • AnMed Health Cancer Center
  • Greenville Health System Cancer Institute-Faris
  • Saint Francis Cancer Center
  • Greenville Health System Cancer Institute-Eastside
  • Self Regional Healthcare
  • Greenville Health System Cancer Institute-Greer
  • Gibbs Cancer Center-Pelham
  • Greenville Health System Cancer Institute-Seneca
  • Spartanburg Medical Center
  • Greenville Health System Cancer Institute-Spartanburg
  • Sanford USD Medical Center - Sioux Falls
  • University of Texas Medical Branch
  • M D Anderson Cancer Center
  • The Methodist Hospital System
  • MD Anderson in Katy
  • UTMB Cancer Center at Victory Lakes
  • MD Anderson League City
  • MD Anderson in Sugar Land
  • MD Anderson in The Woodlands
  • Intermountain Medical Center
  • Central Vermont Medical Center/National Life Cancer Treatment
  • University of Vermont Medical Center
  • Norris Cotton Cancer Center-North
  • Augusta Health Center for Cancer and Blood Disorders
  • Harrison Medical Center
  • PeaceHealth Saint John Medical Center
  • PeaceHealth Southwest Medical Center
  • Wheeling Hospital/Schiffler Cancer Center
  • Aurora Cancer Care-Grafton
  • Aurora BayCare Medical Center
  • Aurora Cancer Care-Kenosha South
  • Bay Area Medical Center
  • Marshfield Medical Center-Marshfield
  • Community Memorial Hospital
  • Ascension Columbia Saint Mary's Hospital Ozaukee
  • Ascension Columbia Saint Mary's Water Tower Medical Commons
  • Aurora Saint Luke's Medical Center
  • Medical College of Wisconsin
  • Zablocki Veterans Administration Medical Center
  • Marshfield Clinic-Minocqua Center
  • Cancer Center of Western Wisconsin
  • Marshfield Medical Center-Rice Lake
  • Saint Michael's Hospital
  • Aurora Medical Center in Summit
  • Vince Lombardi Cancer Clinic-Two Rivers
  • Aurora West Allis Medical Center
  • The Alyce and Elmore Kraemer Cancer Care Center
  • Diagnostic and Treatment Center
  • Aspirus UW Cancer Center
  • Jewish General Hospital
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemoradiation

Metformin + Chemoradiation

Arm Description

60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 8, 2014
Last Updated
June 16, 2023
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02186847
Brief Title
Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
Official Title
Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiation
Arm Type
Active Comparator
Arm Description
60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Arm Title
Metformin + Chemoradiation
Arm Type
Experimental
Arm Description
Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
3-dimensional conformal radiation therapy, 3D-CRT, Intensity-modulated radiation therapy, IMRT
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Metformin HCL, Metformin Hydrochloride
Intervention Description
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),
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Alive Without Progression (Progression-free Survival)
Description
Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: [1] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be > 5 mm. [2] Appearance of ≥1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Secondary Outcome Measure Information:
Title
Percentage of Participants Alive (Overall Survival)
Description
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Title
Percentage of Participants With Local-regional Progression
Description
Local-regional progression (LRP) is defined as progression within the planned treatment volume (PTV) or outside the PTV but within the same lobe(s) of the lung as the primary tumor or in regional lymph nodes. Progression is defined as change in a known lesion(s) meeting one of the following criteria: [1] ≥ 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be > 5 mm. [2] Appearance of ≥1 new lesions. LRP time is defined as time from randomization to the date of first LRP, death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 LRP events were reported.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Title
Percentage of Participants With Distant Metastases
Description
Distant metastasis (DM) is defined as the appearance of ≥ 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
Time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Title
Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
Description
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
Time Frame
From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
34323922
Citation
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.
Results Reference
derived

Learn more about this trial

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

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