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Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial

Trial Status: Active

This phase II / III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). 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 uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

Inclusion Criteria

  • Pathologically proven diagnosis of extensive stage small cell lung cancer
  • Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography [PET]/computed tomography [CT] scan, diagnostic CT scan, magnetic resonance imaging [MRI] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum or 6 weeks from completion of prophylactic cranial irradiation (PCI)
  • At the time of enrollment, patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
  • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
  • Appropriate stage for study entry based on the following diagnostic workup: * History/physical examination within 14 days prior to registration; * Imaging within 42 days prior to registration to include: ** MRI brain with contrast or CT brain with contrast ** CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000/cells/mm^3 (within 14 days prior to registration)
  • Platelets >= 75,000 cells/mm^3 (within 14 days prior to registration)
  • Hemoglobin >= 8 g/dL (within 14 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN (AST and/or ALT =< 5 ULN for patients with liver involvement) (within 14 days prior to registration)
  • Alkaline phosphatase =< 2.5 x ULN (=< 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)
  • Serum creatinine =< 2.0 x ULN (within 14 days prior to registration)
  • Adequate renal function within 30 days prior to registration defined as follows: glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2
  • Upfront radiation therapy of symptomatic metastatic site (excluded brain metastases) is permissible if causing patient pain or impending fracture
  • Patients with bone metastases are eligible. However, to assess response after radiation for bone metastases, must order at least diagnostic CT scan to measure response
  • For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration. * Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: ** Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) ** Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
  • Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • Metastatic disease invading the liver (> 3 metastases), heart or > 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan count as one site. For site of bony metastases, must order diagnostic CT scan for assessment of response * Intracranial, visible brain metastases on radiographic imaging before induction system therapy is excluded
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization. Cancers with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome are eligible (such as adequately treated carcinoma in situ of the cervix or oral cavity; localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent)
  • Prior radiotherapy in the thorax that would result in overlapping radiation therapy (RT) fields, unless the overlapping fields meet dose constraints for this trial
  • History of autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn’s, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener’s granulomatosis; Sjogren’s syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis. Note: the follow are eligible: * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: ** Patients with psoriasis must not have ocular manifestations within the past year ** Rash must cover less than 10% of body surface area (BSA) ** Disease is well controlled on topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) ** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or oral steroids)
  • Severe, active co-morbidity defined as follows: * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications; * Active tuberculosis; * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease ** Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible ** Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test) * Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL); * Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary; * Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months; * History of recent myocardial infarction within 6 months prior to registration. * Clinically significant interstitial lung disease
  • Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Women who are breastfeeding and unwilling to discontinue
  • History of allogeneic organ transplant
  • Patients who have had immunotherapy-induced pneumonitis

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Arizona Cancer Center-North Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-327-2873

Arkansas

Jonesboro
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 870-936-7066

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839

Colorado

Colorado Springs
Memorial Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-364-6700
Penrose-Saint Francis Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Rocky Mountain Cancer Centers-Penrose
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
UCHealth Memorial Hospital Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Poudre Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
UCHealth Greeley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Loveland
Medical Center of the Rockies
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-203-7083

Florida

Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-674-2625
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Miami Beach
Mount Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-674-2625
Weston
Cleveland Clinic-Weston
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-659-5705

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Grady Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-489-9164
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: TEMPORARILY_CLOSED_TO_ACCRUAL
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
Hawaii Cancer Care Inc-Liliha
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-536-4888
Kapiolani Medical Center for Women and Children
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-983-6090
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
University of Hawaii Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-586-2979
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-535-7960

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

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
Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Chicago
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Elmhurst
Elmhurst Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-758-5460
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
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Naperville
Edward Hospital / Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-646-6075
O'Fallon
Cancer Care Center of O'Fallon
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
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
Southern Illinois University School of Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Methodist West Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Wichita
Ascension Via Christi Hospitals Wichita
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-362-0070

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-562-3429

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-888-8823
Bel Air
UM Upper Chesapeake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-643-3010
Columbia
Central Maryland Radiation Oncology in Howard County
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-546-1300
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-553-8100

Massachusetts

Boston
Boston Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-638-8265

Michigan

Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - 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
Trinity Health IHA Medical Group Hematology Oncology - 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
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Flint
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Hurley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 810-762-8038
Kalamazoo
Borgess Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
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
Trinity Health Saint Mary Mercy Livonia Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Midland
MyMichigan Medical Center Midland
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-631-2469
Royal Oak
William Beaumont Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
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
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Troy
William Beaumont Hospital - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411

Minnesota

Albert Lea
Mayo Clinic Health System in Albert Lea
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

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
Columbia
University of Missouri - Ellis Fischel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-882-7440
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066

Montana

Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

Nevada

Reno
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

Camden
Cooper Hospital University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 856-325-6757
Pennington
Capital Health Medical Center-Hopewell
Status: ACTIVE
Contact: Site Public Contact
Phone: 609-394-4130
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 856-325-6757

New Mexico

Albuquerque
Lovelace Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Canandiaqua
Sands Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-396-6161
New York
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: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-275-5830
Wilmot Cancer Institute Radiation Oncology at Greece
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-758-7877
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Albemarle
Atrium Health Stanly / LCI-Albemarle
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Charlotte
Atrium Health Pineville / LCI-Pineville
Status: ACTIVE
Contact: Site Public Contact
Phone: 980-442-2000
Atrium Health University City / LCI-University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Levine Cancer Institute-Ballantyne
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Levine Cancer Institute-SouthPark
Status: ACTIVE
Contact: Site Public Contact
Phone: 980-442-2000
Concord
Atrium Health Cabarrus / LCI-Concord
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Gastonia
Levine Cancer Institute-Gaston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Lincolnton
Atrium Health Lincoln / LCI-Lincolnton
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Monroe
Atrium Health Union / LCI-Union
Status: ACTIVE
Contact: Site Public Contact
Phone: 980-442-2000
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

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

Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-584-7698
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
MetroHealth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-778-8526
Columbus
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
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
Independence
Cleveland Clinic Cancer Center Independence
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Sandusky
North Coast Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
West Chester
University of Cincinnati Cancer Center-West Chester
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-584-7698
Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
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
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
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
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
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
Tualatin
Legacy Meridian Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-1742

Pennsylvania

Broomall
Crozer-Keystone Regional Cancer Center at Broomall
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-284-8237
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Ephrata
Ephrata Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-721-4840
Erie
Saint Vincent Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 814-452-5000
Gettysburg
Adams Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-441-7957
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-3779
Jefferson Hills
Jefferson Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-359-3043
Lebanon
Sechler Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-741-8303
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Monroeville
Forbes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-858-7746
Natrona Heights
Allegheny Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Pittsburgh
Allegheny General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-284-2000
West Penn Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-578-5000
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-836-0388
Wexford
Wexford Health and Wellness Pavilion
Status: ACTIVE
Contact: Site Public Contact
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
York
WellSpan Health-York Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-441-7957
WellSpan Health-York Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Bluffton
Saint Joseph's / Candler - Bluffton Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Gaffney
Gibbs Cancer Center-Gaffney
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104
Greenville
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
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
Greenwood
Self Regional Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-725-4771
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Rock Hill
Levine Cancer Institute-Rock Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Seneca
Prisma Health Cancer Institute - Seneca
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-241-6251
Spartanburg
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Union
MGC Hematology Oncology-Union
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Pierre
Avera Cancer Institute at Pierre
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-322-3095
Sioux Falls
Avera Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-322-3095
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Texas

Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-632-6789
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
League City
MD Anderson League City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789
McKinney
Texas Oncology-McKinney
Status: ACTIVE
Contact: Site Public Contact
Phone: 972-542-8609
Plano
Texas Oncology-Plano West
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Sugar Land
MD Anderson in Sugar Land
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789

Utah

Farmington
Farmington Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100
University of Utah Sugarhouse Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Saint Johnsbury
Norris Cotton Cancer Center-North
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Richmond
VCU Massey Cancer Center at Stony Point
Status: ACTIVE
Contact: Site Public Contact
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Washington

Bellingham
PeaceHealth Saint Joseph Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8238
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

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-623-9869
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
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
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Oak Creek
Drexel Town Square Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-0505
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Wausau
Aspirus Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-405-6866
West Bend
Froedtert West Bend Hospital / Kraemer Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-0505
Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-422-7718

PRIMARY OBJECTIVES:

I. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase II)

II. To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase III)

SECONDARY OBJECTIVES:

I. To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm.

II. To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and > 3 visible tumors.

III. To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”).

EXPLORATORY OBJECTIVE:

I. To assess the association between pre-treatment tumor burden (determined by central radiographic assessment, using both tumor number and tumor volume), and PFS and OS benefit.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive atezolizumab IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Quynh-Nhu Nguyen

  • Primary ID NRG-LU007
  • Secondary IDs NCI-2020-03472
  • Clinicaltrials.gov ID NCT04402788