Chemoradiation with or without Atezolizumab in Treating Patients with Limited Stage Small Cell Lung Cancer

Status: Active

Description

This phase II / III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy
  • Minimal staging requirements include: * History/physical examination within 30 days prior to registration * Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration * CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration – this can be obtained as part of PET/CT if CT imaging is of diagnostic quality ** Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy * Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
  • Absolute neutrophil count (ANC) >= 1, 500/cells/mm^3 (pre-registration cycle)
  • Platelet count >= 100,000 cells/mm^3 (pre-registration cycle)
  • Hemoglobin >= 9 g/dL (pre-registration cycle)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (pre-registration cycle)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 x ULN (pre-registration cycle)
  • Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 (within 30 days prior to registration)
  • 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
  • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • Definitive clinical or radiologic evidence of metastatic disease
  • Definitive surgical resection of small cell lung cancer
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable
  • Any prior atezolizumab or other immunotherapy agent
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs)
  • Patients with cytologically positive pleural or pericardial fluid are not eligible
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
  • History of allogeneic organ transplant
  • History of primary immunodeficiency
  • Severe, active co-morbidity defined as follows: * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease * 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 * Active hepatitis B (chronic or acute) or hepatitis C infection. Note that if hepatitis status is unknown, hepatitis B/C testing is required ** Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) 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) * CD4 count < 200 cells/microliter. Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol * 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 * Transmural myocardial infarction within the last 3 months * Clinically significant interstitial lung disease
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

Locations & Contacts

Arizona

Goodyear
CTCA at Western Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 623-207-3000

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Delaware

Newark
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Lakeland
The Watson Clinic
Status: Active
Contact: Site Public Contact
Phone: 863-680-7780
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

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
Newnan
CTCA at Southeastern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 770-400-6629
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
Memorial Health University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Chicago
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Elmhurst
Elmhurst Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 630-758-5460
Email: Jrohde@emhc.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
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
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Naperville
Edward Hospital / Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 630-646-6075
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: Active
Contact: Site Public Contact
Phone: 630-646-6075
Email: Cancerresearch@edward.org
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Zion
Midwestern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Indiana

Fort Wayne
Parkview Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-784-4673
Goshen
Goshen Center for Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 574-364-2973
Email: cccois@goshenhealth.com

Iowa

Ames
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
West Des Moines
Mercy Medical Center-West Lakes
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org

Kentucky

Louisville
Norton Audubon Hospital and Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 502-629-3465
Norton Brownsboro Hospital and Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Norton Hospital Pavilion and Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 502-629-2500

Louisiana

Baton Rouge
Louisiana Hematology Oncology Associates LLC
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
LSU Health Baton Rouge-North Clinic
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Mary Bird Perkins Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Medical Center of Baton Rouge
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 225-761-5346
Email: Camille.Beck@Ochsner.org
Our Lady of the Lake Physicians Group - Medical Oncology
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Covington
Mary Bird Perkins Cancer Center - Covington
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Houma
Mary Bird Perkins Cancer Center - Houma
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
New Orleans
Ochsner Medical Center Jefferson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org
University Medical Center New Orleans
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Belfast
Waldo County General Hospital
Status: Active
Contact: Site Public Contact
Phone: 207-338-2500
Norway
Stephens Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 207-396-8670
Email: OncClinicalResearch@mmc.org
Portland
Maine Medical Center-Bramhall Campus
Status: Active
Contact: Site Public Contact
Phone: 207-885-7565
Rockport
Penobscot Bay Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-396-8670
Email: ClinicalResearch@mmc.org
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
MaineHealth Cancer Care Center of York County
Status: Active
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: Active
Contact: Site Public Contact
Phone: 207-396-8090
Email: wrighd@mmc.org
South Portland
Maine Medical Partners - South Portland
Status: Active
Contact: Site Public Contact
Phone: 207-396-8670
Email: ClinicalResearch@mmc.org

Maryland

Baltimore
Saint Agnes Hospital
Status: Active
Contact: Site Public Contact
Phone: 410-368-2910

Massachusetts

Worcester
UMass Memorial Medical Center - University Campus
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bay City
McLaren Cancer Institute-Bay City
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Brighton
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Canton
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clarkston
21st Century Oncology MHP - Clarkston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-338-0663
McLaren Cancer Institute-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Farmington Hills
21st Century Oncology MHP - Farmington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-338-0663
Flint
McLaren Cancer Institute-Flint
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Singh and Arora Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lansing
McLaren-Greater Lansing
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Mid-Michigan Physicians-Lansing
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Mount Clemens
McLaren Cancer Institute-Macomb
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Port Huron
McLaren-Port Huron
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Saginaw
Ascension Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Marie Yeager Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Troy
21st Century Oncology MHP - Troy
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-338-0663

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Duluth
Saint Luke's Hospital of Duluth
Status: Active
Contact: Site Public Contact
Phone: 218-249-7825
Email: kdean@slhduluth.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-229-4907
Email: coborncancercenter@centracare.com

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Jefferson City
Capital Region Southwest Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Kansas City
The University of Kansas Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569

Nebraska

Grand Island
CHI Health Saint Francis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Las Vegas
OptumCare Cancer Care at Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Oakey
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Radiation Oncology Centers of Nevada Central
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Reno
Renown Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: Active
Contact: Site Public Contact
Phone: 603-224-2556
Hooksett
New Hampshire Oncology Hematology PA-Hooksett
Status: Active
Contact: Site Public Contact
Phone: 800-339-6484

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 607-271-7000
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Asheboro
Randolph Hospital
Status: Active
Contact: Site Public Contact
Phone: 336-832-0836
Email: vivian.sheidler@conehealth.com
Burlington
Cone Health Cancer Center at Alamance Regional
Status: Active
Contact: Site Public Contact
Phone: 336-538-7725
Email: kaye.shoffner@conehealth.com
Greensboro
Cone Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 336-832-0821
Email: vivian.sheidler@conehealth.com
Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-696-4716
Email: karen.morris@unchealth.unc.edu
Kernersville
Novant Health Oncology Specialists-Kernersville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Mount Airy
Novant Health Oncology Specialists-Mount Airy
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 910-715-3500
Email: jcwilliams@firsthealth.org
Stateville
Novant Health Oncology Specialists-Statesville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Thomasville
Novant Health Oncology Specialists-Davidson County
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Wilkesboro
Novant Health Oncology Specialists-Wilkesboro
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org
Winston-Salem
Novant Health Forsyth Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-718-8335
Email: asmarrs@novanthealth.org

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Grand Forks
Altru Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-780-6520

Ohio

Akron
Summa Health System - Akron Campus
Status: Active
Contact: Site Public Contact
Phone: 330-375-4221
Email: cancerresearch@summahealth.org
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Canton
Aultman Health Foundation
Status: Active
Contact: Site Public Contact
Phone: 330-363-7274
Email: ClinicalReserachDept@aultman.com
Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Columbus
Doctors Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Grant Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Mount Carmel East Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mansfield
OhioHealth Mansfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Newark
Licking Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Parma
University Hospitals Parma Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Wadsworth
University Hospitals Sharon Health Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
West Chester
University Pointe
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com
Westlake
UH Seidman Cancer Center at Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
UHHS-Westlake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org

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
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Cancer Treatment Centers of America
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-413-2150
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Ephrata
Ephrata Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 717-721-4840
Gettysburg
Adams Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
Hanover
Cherry Tree Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
Lancaster
Lancaster General Hospital
Status: Active
Contact: Site Public Contact
Phone: 717-544-5511
Lebanon
Sechler Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 717-741-8303
Email: doxenberg@wellspan.org
Media
Riddle Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Newtown Square
Bryn Mawr Health Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Paoli
Paoli Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Philadelphia
Eastern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Thomas Jefferson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 215-955-6084
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-836-0388
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
York
WellSpan Health-York Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Spartanburg
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

South Dakota

Rapid City
Rapid City Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 605-716-3982
Email: research@rcrh.org
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Knoxville
Thompson Cancer Survival Center
Status: Active
Contact: Site Public Contact
Phone: 865-331-1812

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 434-243-6303
Email: PAS9E@virginia.edu
Fishersville
Augusta Health Center for Cancer and Blood Disorders
Status: Active
Contact: Site Public Contact
Phone: 540-332-5960

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Bremerton
Harrison Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Vancouver
Legacy Salmon Creek Hospital
Status: Temporarily closed to accrual
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
Email: Juli.Alford@aspirus.org
Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Mayo Clinic Health System-Franciscan Healthcare
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Zablocki Veterans Administration Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-469-6614
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. (Phase II)

II. To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab. (Phase III)

SECONDARY OBJECTIVES:

I. To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. (Phase III)

II. To determine overall response rate (ORR), rates of local control, and distant metastases free survival with chemoradiation +/- atezolizumab.

III. To characterize immune mediated and non-immune mediated toxicity from chemoradiotherapy plus atezolizumab.

IV. To compare quality of life, as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI), for patients undergoing chemoradiation +/- atezolizumab.

V. To evaluate the quality-adjusted survival, using scores from the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L), of chemoradiation +/- atezolizumab for patients with LS-SCLC.

VI. To characterize fatigue, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS), following chemoradiation +/- atezolizumab.

VII. To determine the association of blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB) with clinical outcome.

EXPLORATORY OBJECTIVES:

I. To collect biospecimens at baseline, Day 1 and 3 months after the end of chemoradiotherapy, to allow for future analyses.

II. To characterize patient-reported symptomatic toxicities measured by the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Evens (PRO-CTCAE).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive etoposide intravenously (IV) on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) twice daily (BID) for approximately 3 weeks or once daily (QD) for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity.

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

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Kristin Ann Higgins

Trial IDs

Primary ID NRG-LU005
Secondary IDs NCI-2019-00178
Clinicaltrials.gov ID NCT03811002