Purpose

This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion Criteria:

- Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint
Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease).
Patients with stage IIIB and IIIC disease are eligible if they are not a candidate
for combined chemotherapy and radiation

- PD-L1 expression tumor proportion score (TPS) < 1% in tumor cells. If PD-L1
expression TPS is unevaluable or the testing could not be completed patients are not
eligible. The assay must have been performed locally by a Clinical Laboratory
Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will
be recorded

- For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1
testing must be done locally. No patients with known actionable EGFR mutations
(except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral
tyrosine inhibitors

- Measurable disease based on RECIST 1.1, including at least two cancerous deposits.
At least one deposit must be RECIST measurable (and not to be irradiated) while at
least one OTHER deposit (measurable or non-measurable) must meet criteria for three
8 gray (Gy) doses of radiation

- Age >= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- No more than three weeks of treatment with systemic chemotherapy or immunotherapy
for advanced NSCLC

- No more than three weeks of treatment with checkpoint inhibitors for metastatic lung
cancer

- No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g.,
adjuvant therapy) within 6 months prior to registration

- No systemic immunostimulatory or immunosuppressive drugs, including > 10 mg
prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever
is shorter. Steroid premedication per local standard is allowed

- >= 1 week prior to registration since palliative (including central nervous system
[CNS]) radiotherapy to any tumor site

- No prior allogeneic tissue/solid organ transplant

- No uncontrolled intercurrent illness including, but not limited to, serious ongoing
or active infection, symptomatic congestive heart failure, uncontrolled cardiac
arrhythmia, unstable angina pectoris, that would limit compliance with study
requirements

- No current pneumonitis or history of non-infectious pneumonitis that required
steroids

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of registration

- No active auto-immune disease that requires systemic therapy within 2 years prior to
registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic
corticosteroid release therapy for adrenal or pituitary insufficiency) is not
considered a form of systemic treatment and is allowed

- No known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA]
[qualitative] is detected) infection

- No patients with symptomatic central nervous system metastases and/or carcinomatous
meningitis. Patients with small asymptomatic brain metastases are eligible as are
patients with treated brain metastases that require no steroids

- Not pregnant and not nursing, because this study involves radiation as well as
potentially chemotherapy which have known genotoxic, mutagenic and teratogenic
effects. Therefore, for women of childbearing potential only, a negative urine or
serum pregnancy test done =< 7 days prior to registration is required

- No patients with a "currently active" second malignancy that is progressing or has
required active treatment within the last 2 years. Participants with non-melanoma
skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or
cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have
undergone potentially curative therapy are eligible

- No hypersensitivity (>= grade 3) to immunotherapy and/or any of its excipients

- No live vaccine within 30 days prior to registration. Examples of live vaccines
include, but are not limited to, the following: measles, mumps, rubella,
varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin
(BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally
killed virus vaccines and are allowed; however, intranasal influenza vaccines
(e.g.,FluMist [registered trademark]) are live attenuated vaccines and are not
allowed. COVID-19 vaccine is allowed

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Calculated (Calc.) creatinine clearance >= 45 mL/min

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN)

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (immunotherapy, +/- chemotherapy)
Patients receive nivolumab intravenously (IV) over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
  • Procedure: Biopsy Procedure
    Undergo tissue biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Biological: Ipilimumab
    Given IV
    Other names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS 734016
    • BMS-734016
    • BMS734016
    • Ipilimumab Biosimilar CS1002
    • MDX 010
    • MDX-010
    • MDX-CTLA4
    • MDX010
    • Yervoy
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Biological: Nivolumab
    Given IV
    Other names:
    • ABP 206
    • BCD-263
    • BMS 936558
    • BMS-936558
    • BMS936558
    • CMAB819
    • MDX 1106
    • MDX-1106
    • MDX1106
    • NIVO
    • Nivolumab Biosimilar ABP 206
    • Nivolumab Biosimilar BCD-263
    • Nivolumab Biosimilar CMAB819
    • ONO 4538
    • ONO-4538
    • ONO4538
    • Opdivo
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
Experimental
Arm B (immunotherapy, +/- chemotherapy, radiation therapy)
Patients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of radiation therapy every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
  • Procedure: Biopsy Procedure
    Undergo tissue biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Biological: Ipilimumab
    Given IV
    Other names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS 734016
    • BMS-734016
    • BMS734016
    • Ipilimumab Biosimilar CS1002
    • MDX 010
    • MDX-010
    • MDX-CTLA4
    • MDX010
    • Yervoy
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Biological: Nivolumab
    Given IV
    Other names:
    • ABP 206
    • BCD-263
    • BMS 936558
    • BMS-936558
    • BMS936558
    • CMAB819
    • MDX 1106
    • MDX-1106
    • MDX1106
    • NIVO
    • Nivolumab Biosimilar ABP 206
    • Nivolumab Biosimilar BCD-263
    • Nivolumab Biosimilar CMAB819
    • ONO 4538
    • ONO-4538
    • ONO4538
    • Opdivo
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • Energy Type
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Site Public Contact
501-686-8274

Alta Bates Summit Medical Center-Herrick Campus
Berkeley 5327684, California 5332921 94704
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

City of Hope at Irvine Lennar
Irvine 5359777, California 5332921 92618
Contact:
Site Public Contact
877-467-3411

City of Hope Antelope Valley
Lancaster 5364940, California 5332921 93534
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Fremont - Rideout Cancer Center
Marysville 5370984, California 5332921 95901
Contact:
Site Public Contact
530-749-4400

Memorial Medical Center
Modesto 5373900, California 5332921 95355
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Providence Queen of The Valley
Napa 5376095, California 5332921 94558
Contact:
Site Public Contact
707-521-3830

University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817
Contact:
Site Public Contact
916-734-3089

City of Hope South Pasadena
South Pasadena 5397717, California 5332921 91030
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee 5403676, California 5332921 96161
Contact:
Site Public Contact
530-582-6450

City of Hope Upland
Upland 5404915, California 5332921 91786
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Beebe South Coastal Health Campus
Millville 4143696, Delaware 4142224 19967
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Helen F Graham Cancer Center
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Beebe Health Campus
Rehoboth Beach 4144284, Delaware 4142224 19971
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

UM Sylvester Comprehensive Cancer Center at Aventura
Aventura 4146429, Florida 4155751 33180
Contact:
Site Public Contact
954-461-2180

Morton Plant Hospital
Clearwater 4151316, Florida 4155751 33756
Contact:
Site Public Contact
855-314-8646

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables 4151871, Florida 4155751 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Kendall
Miami 4164138, Florida 4155751 33176
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation 4168782, Florida 4155751 33324
Contact:
Site Public Contact
305-243-2647

Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa 4174757, Florida 4155751 33607
Contact:
Site Public Contact
813-357-0849
jennifer.manns@baycare.org

Winter Haven Hospital
Winter Haven 4178552, Florida 4155751 33881
Contact:
Site Public Contact
803-293-1121
Research.CTO@baycare.org

CTCA at Southeastern Regional Medical Center
Newnan 4212684, Georgia 4197000 30265
Contact:
Site Public Contact
770-400-6629

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah 4221552, Georgia 4197000 31405
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Saint Luke's Cancer Institute - Boise
Boise 5586437, Idaho 5596512 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Fruitland
Fruitland 5593708, Idaho 5596512 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian 5600685, Idaho 5596512 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Nampa
Nampa 5601933, Idaho 5596512 83687
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls 5610810, Idaho 5596512 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Illinois
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-355-3046

University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Northwestern Medicine Glenview Outpatient Center
Glenview 4893886, Illinois 4896861 60026
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Grayslake Outpatient Center
Grayslake 4894465, Illinois 4896861 60030
Contact:
Site Public Contact
312-695-1102

Ingalls Memorial Hospital
Harvey 4895298, Illinois 4896861 60426
Contact:
Site Public Contact
708-915-4673
clinicaltrials@ingalls.org

Northwestern Medicine Lake Forest Hospital
Lake Forest 4899012, Illinois 4896861 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

Carle Physician Group-Mattoon/Charleston
Mattoon 4244099, Illinois 4896861 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

UC Comprehensive Cancer Center at Silver Cross
New Lenox 4903535, Illinois 4896861 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

HSHS Saint Elizabeth's Hospital
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

University of Chicago Medicine-Orland Park
Orland Park 4904937, Illinois 4896861 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

UW Health Carbone Cancer Center Rockford
Rockford 4907959, Illinois 4896861 61114
Contact:
Site Public Contact
779-696-9378
lkline@uwhealth.org

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
800-444-7541

Springfield Memorial Hospital
Springfield 4250542, Illinois 4896861 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Mary Greeley Medical Center
Ames 4846834, Iowa 4862182 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic - Ames
Ames 4846834, Iowa 4862182 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-241-3305

Mercy Cancer Center-West Lakes
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-241-3305

Greater Regional Medical Center
Creston 4853078, Iowa 4862182 50801
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305

Mercy Medical Center - Des Moines
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-241-3305

UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee 4880981, Iowa 4862182 50263
Contact:
Site Public Contact
515-241-3305

Mercy Medical Center-West Lakes
West Des Moines 4881346, Iowa 4862182 50266
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Saint Joseph Hospital East
Lexington 4297983, Kentucky 6254925 40509
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
Contact:
Site Public Contact
859-257-3379

MaineHealth Cancer Care Center of York County
Sanford 4977762, Maine 4971068 04073
Contact:
Site Public Contact
207-459-1600

MaineHealth Maine Medical Center- Scarborough
Scarborough 4977882, Maine 4971068 04074
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

MaineHealth Cancer Care and IV Therapy - South Portland
South Portland 4979244, Maine 4971068 04106
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Genesys Hurley Cancer Institute
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Bronson Methodist Hospital
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing 4998830, Michigan 5001836 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia 4999837, Michigan 5001836 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

MyMichigan Medical Center Saginaw
Saginaw 5007989, Michigan 5001836 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

MyMichigan Medical Center Tawas
Tawas City 5011900, Michigan 5001836 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Miller-Dwan Hospital
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Hennepin County Medical Center
Minneapolis 5037649, Minnesota 5037779 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

North Memorial Medical Health Center
Robbinsdale 5043439, Minnesota 5037779 55422
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul 5045360, Minnesota 5037779 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Medical Center
Cape Girardeau 4379966, Missouri 4398678 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Parkland Health Center - Farmington
Farmington 4386289, Missouri 4398678 63640
Contact:
Site Public Contact
314-996-5569

Phelps Health Delbert Day Cancer Institute
Rolla 4406282, Missouri 4398678 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Sainte Genevieve County Memorial Hospital
Sainte Genevieve 4407294, Missouri 4398678 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
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314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
St Louis 4407066, Missouri 4398678 63131
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314-996-5569

Missouri Baptist Sullivan Hospital
Sullivan 4410669, Missouri 4398678 63080
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314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills 4410836, Missouri 4398678 63127
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314-996-5569

Bozeman Health Deaconess Hospital
Bozeman 5641727, Montana 5667009 59715
Contact:
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406-969-6060
mccinfo@mtcancer.org

Northwell Health/Center for Advanced Medicine
Lake Success 5123853, New York 5128638 11042
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516-734-8896

Manhattan Eye Ear and Throat Hospital
New York 5128581, New York 5128638 10065
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212-434-4460

Lenox Hill Hospital
New York 5128581, New York 5128638 10075
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516-734-8896

Upstate Cancer Center at Oswego
Oswego 5130081, New York 5128638 13126
Contact:
Site Public Contact
315-464-8230
McDowelE@upstate.edu

Upstate Cancer Center Radiation Oncology at Oswego
Oswego 5130081, New York 5128638 13126
Contact:
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315-464-3603
BinghamE@upstate.edu

State University of New York Upstate Medical University
Syracuse 5140405, New York 5128638 13210
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315-464-5476

Upstate Cancer Center at Hill Radiation Oncology
Syracuse 5140405, New York 5128638 13210
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315-464-3603
BinghamE@upstate.edu

SUNY Upstate Medical Center-Community Campus
Syracuse 5140405, New York 5128638 13215
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315-464-5476

Upstate Cancer Center at Verona
Verona 5142333, New York 5128638 13478
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315-464-8230
McDowelE@upstate.edu

Duke Cancer Center Raleigh
Raleigh 4487042, North Carolina 4482348 27609
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NCTNStudyTeam@dm.duke.edu

Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157
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336-713-6771

Summa Health System - Akron Campus
Akron 5145476, Ohio 5165418 44304
Contact:
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330-375-4221
cancerresearch@summahealth.org

Cancer Centers of Southwest Oklahoma Research
Lawton 4540737, Oklahoma 4544379 73505
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877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
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405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City 4544349, Oklahoma 4544379 73120
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405-752-3402

Legacy Mount Hood Medical Center
Gresham 5729485, Oregon 5744337 97030
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503-413-2150

Legacy Good Samaritan Hospital and Medical Center
Portland 5746545, Oregon 5744337 97210
Contact:
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800-220-4937
cancer@lhs.org

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
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503-494-1080
trials@ohsu.edu

Legacy Meridian Park Hospital
Tualatin 5757506, Oregon 5744337 97062
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503-413-1742

Christiana Care Health System-Concord Health Center
Chadds Ford 4557084, Pennsylvania 6254927 19317
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302-623-4450
lbarone@christianacare.org

Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
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570-271-5251
HemonCCTrials@geisinger.edu

Penn State Milton S Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033-0850
Contact:
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717-531-3779
CTO@hmc.psu.edu

Geisinger Medical Oncology-Lewisburg
Lewisburg 5197842, Pennsylvania 6254927 17837
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570-374-8555
HemonCCTrials@geisinger.edu

Penn State Health Saint Joseph Medical Center
Reading 5207728, Pennsylvania 6254927 19605
Contact:
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610-378-2336
dward1@pennstatehealth.psu.edu

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
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570-271-5251
HemonCCTrials@geisinger.edu

The Don and Sybil Harrington Cancer Center
Amarillo 5516233, Texas 4736286 79106
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806-212-1985
Gina.Cravey@bsahs.org

VCU Massey Cancer Center at Stony Point
Richmond 4781708, Virginia 6254928 23235
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ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928 23298
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804-628-6430
CTOclinops@vcu.edu

Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver 5814616, Washington 5815135 98684
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oncologyresearch@lhs.org

Legacy Salmon Creek Hospital
Vancouver 5814616, Washington 5815135 98686
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503-413-2150

West Virginia University Charleston Division
Charleston 4801859, West Virginia 4826850 25304
Contact:
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304-388-9944

Northwest Wisconsin Cancer Center
Ashland 5244247, Wisconsin 5279468 54806
Contact:
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218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Medical Center-EC Cancer Center
Eau Claire 5251436, Wisconsin 5279468 54701
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468 54449
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Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Minocqua
Minocqua 5263156, Wisconsin 5279468 54548
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago 5263965, Wisconsin 5279468 53149
Contact:
Site Public Contact
research.institute@phci.org

Cancer Center of Western Wisconsin
New Richmond 5264475, Wisconsin 5279468 54017
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

ProHealth Oconomowoc Memorial Hospital
Oconomowoc 5265499, Wisconsin 5279468 53066
Contact:
Site Public Contact
262-928-7878

Marshfield Medical Center-Rice Lake
Rice Lake 5268798, Wisconsin 5279468 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54482
Contact:
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

UW Cancer Center at ProHealth Care
Waukesha 5278052, Wisconsin 5279468 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Marshfield Medical Center - Weston
Weston 5278693, Wisconsin 5279468 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

More Details

NCT ID
NCT04929041
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVE: I. To assess if radiation improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage non-small cell lung cancer (NSCLC) patients with PD-L1 tumor proportion score (TPS) < 1% who receive immunotherapy with or without chemotherapy. SECONDARY OBJECTIVES: I. To estimate and compare the rates of >= grade 3-4 and all grade adverse events by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 between the arms. II. To summarize and compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) between the arms. III. To determine and compare the objective response rate (ORR) per RECIST between the arms (including at both irradiated and un-irradiated sites). QUALITY OF LIFE (QOL) OBJECTIVE: I. To assess the health-related QOL in both treatment arms. CORRELATIVE SCIENCE OBJECTIVE: I. To evaluate changes in the peripheral immune microenvironment between the arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET) throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as echocardiography (ECHO) during screening. Arm B: Patients receive nivolumab IV over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo 3 fractions of radiation therapy every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. After completion of study treatment, patients are followed up every 3 months for 3 years and then every 6 months for years 4-5 following randomization until disease progression. Following disease progression patients are followed for survival every 6 months for up to 5 years following randomization.

Notice

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