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NCT02186847

PHASE2

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2014-08

Completion Date

2025-09-04

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Adenosquamous Lung Carcinoma Bronchioloalveolar Carcinoma Large Cell Lung Carcinoma Lung Adenocarcinoma Non-Small Cell Lung Carcinoma Recurrent Non-Small Cell Lung Carcinoma Squamous Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer

Interventions

RADIATION

Radiation Therapy

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).

DRUG

Carboplatin

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.

DRUG

Metformin

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),

DRUG

Paclitaxel

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.

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

Locations (223)

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Memorial Medical Center

Modesto, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Cancer Center of Putnam

Palatka, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

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

Savannah, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Northwest Community Hospital

Arlington Heights, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

IU Health Bloomington

Bloomington, Indiana, United States

Radiation Oncology Associates PC

Fort Wayne, Indiana, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Baptist Health Hardin

Elizabethtown, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center - Covington

Covington, Louisiana, United States

Mary Bird Perkins Cancer Center - Houma

Houma, Louisiana, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

TidalHealth Peninsula Regional

Salisbury, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Lowell General Hospital

Lowell, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

And 123 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (223)