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Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients with Early Non-small Cell Lung Cancer

Trial Status: Active

This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Inclusion Criteria

  • Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of multifocal tumors and pericardial involvement
  • Disease must have one or more of the following high-risk features: * Tumor diameter >= 2 cm as assessed by diagnostic computed tomography (CT) * Tumor standard uptake value (SUV) max >= 6.2 as assessed by fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT * Moderately differentiated, poorly differentiated, or undifferentiated histology
  • Patient must have undergone diagnostic chest CT with contrast (unless medically contraindicated) within 42 days prior to randomization. PET-CT may be used if the CT portion is of identical diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization
  • Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization
  • Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional
  • Patient must have undergone history and physical examination within 28 days prior to randomization
  • Patient must be medically or surgically inoperable as documented by a board certified thoracic surgeon or multi-disciplinary tumor board consensus OR patient’s unwillingness to undergo surgical resection must be clearly documented
  • Patient must not have received any prior treatment for the current NSCLC diagnosis
  • Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
  • Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization
  • Patient must be >= 18 years old
  • Patient must have Zubrod performance status of 0-2
  • Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization
  • Patient must have adequate renal function defined as calculated creatinine clearance >= 30 mL/min using the following formula. The serum creatinine value used in the calculation must have been collected within 28 days prior to randomization
  • Patient must have absolute neutrophil count (ANC), platelets, and hemoglobin measured within 28 days prior to randomization. The purpose of these tests is to collect baseline values to compare with on-treatment values
  • Patient must have thyroid-stimulating hormone (TSH) measured within 28 days prior to randomization. The purpose of this test is to collect baseline values to compare with on-treatment values
  • Patient must not have significant cardiovascular disease (New York Heart Association [NYHA] class II or greater)
  • Patient must not have myocardial infarction within 90 days prior to randomization
  • Patient must not have unstable arrhythmias or unstable angina
  • Patient must not have known left ventricular ejection fraction < 40% within 28 days prior to randomization
  • Patient must not have had an infection >= grade 3 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) within 28 days prior to randomization
  • Patient must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • Patient must be tested for hepatitis B within 28 days prior to randomization. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection. Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test. Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test
  • Patient must be tested for hepatitis C within 28 days prior to randomization. Patient must not have active hepatitis C virus (HCV) infection. Active HCV is defined as having a positive HCV antibody test followed by a positive HCV RNA test
  • Patient must have an forced expiratory volume in 1 second (FEV1) >= 700 cc and a diffusion capacity of the lung for carbon monoxide (DLCO) >= 5.5 m/min/mmHg from pulmonary function testing documented within 90 days prior to randomization
  • Patient must not have known human immunodeficiency virus (HIV) unless he/she is on effective anti-retroviral therapy, has had at least one viral load test within 6 months prior to randomization, and had undetectable viral load at all viral load tests within 6 months prior to randomization
  • Patient must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT
  • Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the treating physician) to interfere with the safety or efficacy assessment of the investigational regimen
  • Patients must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of “reproductive potential” if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to randomization
  • Patient must agree to have specimens submitted for translational medicine and banking
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Patients who can complete quality of life instruments in English, French, or Spanish must agree to complete the questionnaires at the protocol-specified time points

Alaska

Anchorage
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arkansas

Jonesboro
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 870-936-7066
Little Rock
University of Arkansas for Medical Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-686-8274

California

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Loma Linda
Loma Linda University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 909-558-4050
Veterans Affairs Loma Linda Healthcare System
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-741-8387
Long Beach
Tibor Rubin VA Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 562-826-8000
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Fremont - Rideout Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 530-749-4400
Orange
Saint Joseph Hospital - Orange
Status: ACTIVE
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839
Palm Springs
Desert Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 760-416-4730
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Sutter Roseville Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Sacramento
Sutter Medical Center Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
California Pacific Medical Center-Pacific Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 530-582-6450

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-364-6700
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
UCHealth Memorial Hospital Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-365-2406
Denver
Kaiser Permanente-Franklin
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-720-2685
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: ACTIVE
Contact: Site Public Contact
Poudre Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
North Colorado Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
UCHealth Greeley Hospital
Status: ACTIVE
Contact: Site Public Contact
Lafayette
Kaiser Permanente-Rock Creek
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-720-2685
Lone Tree
Kaiser Permanente-Lone Tree
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-720-2685
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Medical Center of the Rockies
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-203-7083

Delaware

Dover
Bayhealth Hospital Kent Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-744-6755
Newark
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100

Florida

Aventura
GenesisCare USA - Aventura
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
GenesisCare USA - Aventura FP
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Plantation
GenesisCare USA - Plantation
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700

Georgia

Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-721-2388
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Memorial Health University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-350-7887

Hawaii

Aiea
Hawaii Cancer Care - Savio
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-539-2273
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-486-6000
Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-524-6115
Queen's Cancer Cenrer - POB I
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Cancer Center - Kuakini
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-531-8521
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-545-8548
Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-522-4333
The Cancer Center of Hawaii-Liliha
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-547-6881

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Chicago
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-528-7541
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Iowa

Ames
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-643-2196
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-643-2196
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-643-2196
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-643-2196
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-643-2196
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-643-2196

Louisiana

Baton Rouge
LSU Health Baton Rouge-North Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Louisiana Hematology Oncology Associates LLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353
Mary Bird Perkins Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353
Our Lady of the Lake Physicians Group - Medical Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Houma
Mary Bird Perkins Cancer Center - Houma
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353
Terrebonne General Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 985-850-6300

Massachusetts

Beverly
Beverly Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 978-922-3000ext2405
Burlington
Lahey Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 781-744-3421
Gloucester
Addison Gilbert Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 978-283-4000ext559

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Clarkston
GenesisCare USA - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Dearborn
Beaumont Hospital - Dearborn
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Farmington Hills
Beaumont Hospital - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
GenesisCare USA - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Flint
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Kalamazoo
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-364-9400
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Macomb
GenesisCare USA - Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Novi
Ascension Providence Hospitals - Novi
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Pontiac
21st Century Oncology-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Southfield
Ascension Providence Hospitals - Southfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Troy
GenesisCare USA - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Warren
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Duluth
Miller-Dwan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Minneapolis
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Grenada
Baptist Cancer Center-Grenada
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Jackson
University of Mississippi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 601-815-6700
New Albany
Baptist Memorial Hospital and Cancer Center-Union County
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Saint Louis
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Bellevue
Nebraska Medicine-Bellevue
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941
Grand Island
CHI Health Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-313-2409
Kearney
CHI Health Good Samaritan
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-865-7963
Omaha
Nebraska Medicine-Village Pointe
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-5600
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Pennington
Capital Health Medical Center-Hopewell
Status: ACTIVE
Contact: Site Public Contact
Phone: 609-394-4130

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 607-271-7000
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Mount Sinai Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai West
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Asheville
Messino Cancer Centers
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-212-7021
Gastonia
CaroMont Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 704-834-2810
Hendersonville
Margaret R Pardee Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-696-4716
New Bern
CarolinaEast Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-634-6589
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-715-3500
Supply
NHRMC Radiation Oncology - Supply
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-754-4716
Wilmington
NHRMC Radiation Oncology - 16th Street
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-251-1839
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-342-3000

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Cleveland
MetroHealth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-778-8526
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Gresham
Legacy Mount Hood Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-220-4937
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Drexel Hill
Delaware County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-284-8237
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251

South Carolina

Florence
McLeod Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-777-0770
Greenville
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Spartanburg
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

Tennessee

Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Kingsport
Regional Cancer Center at Indian Path Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Wellmont Holston Valley Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Utah

Salt Lake City
George E Wahlen Department of Veterans Affairs Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-582-1565
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Virginia

Fishersville
Augusta Health Center for Cancer and Blood Disorders
Status: ACTIVE
Contact: Site Public Contact
Phone: 540-332-5960
Norton
Southwest VA Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538

Washington

Vancouver
Legacy Cancer Institute Medical Oncology and Day Treatment
Status: ACTIVE
Contact: Site Public Contact
Legacy Salmon Creek Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Huntington
Edwards Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-399-6617

Wisconsin

Appleton
ThedaCare Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-364-3605
Ashland
Northwest Wisconsin Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Franklin
Ascension Saint Francis - Reiman Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Germantown
Aurora Health Care Germantown Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Grafton
Aurora Cancer Care-Grafton
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Bellin Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-435-8326
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Mayo Clinic Health System-Franciscan Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Marinette
Aurora Bay Area Medical Group-Marinette
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Mequon
Ascension Columbia Saint Mary's Hospital Ozaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Milwaukee
Ascension Columbia Saint Mary's Hospital - Milwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Aurora Cancer Care-Milwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Racine
Aurora Cancer Care-Racine
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Summit
Aurora Medical Center in Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Waukesha
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539
Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Aurora Cancer Care-Milwaukee West
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
West Allis
Aurora West Allis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304

PRIMARY OBJECTIVE:

I. To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.

SECONDARY OBJECTIVES:

I. To compare investigator-assessed progression-free survival (IA-PFS) between the arms.

II. To compare progression free survival (PFS) by blinded independent centralized review (BIRC) between the arms in a random subset of patients.

III. To evaluate distant, locoregional, and local failure rates within each treatment arm.

IV. To evaluate the frequency and severity of toxicities within each treatment arm.

ADDITIONAL OBJECTIVE:

I. To collect specimens for banking.

HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVE:

I. To assess quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)-30 and EORTC-QLQ- Lung Cancer (LC)13 between the arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Treatment repeats every 21 days for 8 cycles. Starting on day 1 cycle 3, patients also undergo SBRT for 3-5 treatments over 1-3 weeks.

ARM B: Beginning 21 days after randomization, patients undergo SBRT for 3-5 treatments over 1-3 weeks.

After completion of study treatment, patients are followed up at weeks 18, 30, 42, and 54, every 6 months for 2 years, and then every 12 months for 2 years.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Megan Eileen Daly

  • Primary ID S1914
  • Secondary IDs NCI-2019-08627
  • Clinicaltrials.gov ID NCT04214262