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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 NSCLC
  • Patient must not have undergone prior radiation to overlapping regions of the chest (such that protocol lung constraints cannot be met with a cumulative plan)
  • 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
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized prostate cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • 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

California

Long Beach
Tibor Rubin VA Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 562-826-8000
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sutter Roseville Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sacramento
Sutter Medical Center Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
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: 415-209-2686

Illinois

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
Decatur
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
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
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
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
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541

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: 308-398-6518
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 781-744-3421

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Clarkston
21st Century Oncology MHP - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-338-0663
Dearborn
Beaumont Hospital - Dearborn
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Farmington Hills
21st Century Oncology MHP - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-338-0663
Beaumont Hospital - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Kalamazoo
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Novi
Ascension Providence Hospitals - Novi
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Southfield
Ascension Providence Hospitals - Southfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Troy
21st Century Oncology MHP - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-338-0663
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
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

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

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

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: 800-255-3440

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
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
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-715-3500

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

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

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

Virginia

Fishersville
Augusta Health Center for Cancer and Blood Disorders
Status: ACTIVE
Contact: Site Public Contact
Phone: 540-332-5960

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

Wisconsin

Ashland
Northwest Wisconsin Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308

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.

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