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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02186847

Run by

NRG Oncology

People needed

170

Starts

2014-08-01

Expected to finish

2025-09-04

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified)
• Patients must have measurable disease
• Patients must have unresectable disease, be medically inoperable, or unwilling to undergo surgical management
• Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
• History/physical examination, including documentation of height, weight, body surface area, and vital signs, within 30 days prior to registration
• Computed tomography (CT) with IV contrast or magnetic resonance imaging (MRI) imaging (if CT scan with contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands, required within 45 days prior to registration (recommended within 30 days prior to registration
• MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 45 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT; an MRI without contrast is only permitted if the patient has a contrast allergy
• Whole-body fludeoxyglucose (FDG)-positron emission tomography (PET)/CT required within 45 days prior to registration (recommended within 30 days prior to registration; note: patients do not need to have a separate CT of the chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT with contrast
• Zubrod performance status 0-1
• Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3
• Complete blood count(CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets >= 100,000 cells/mm\^3
• Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
• Adequate renal function within 14 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance must be at least 60 ml/min;
• 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;

You may not qualify if…

• Patients with mixed small cell and non-small cell histologies
• Patients with distant metastasis
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Patients currently using metformin (metformin hydrochloride), other oral hypoglycemic agents or insulin
• Patients with any history of allergic reaction to paclitaxel or other taxanes or carboplatin
• Patients with a history of chronic kidney disease or lactic acidosis
• Patients with >= 10% weight loss within the past month
• Severe, active co-morbidity, defined as follows:
• Diagnosis of type I or type II diabetes mellitus
• Uncontrolled neuropathy >= grade 2 regardless of cause
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• 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

Where it is running

• 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
• Lewis and Faye Manderson Cancer Center — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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