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Purpose

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine 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. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Conditions

Eligibility

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

Inclusion Criteria

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trial and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child.
  • Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 30 days prior to registration
  • Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least CT chest through the adrenals or PET/CT within 30 days prior to registration
  • Zubrod performance status 0, 1, or 2 within 30 days prior to registration
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease
  • Total bilirubin ≤ 1.5 × ULN
  • Absolute neutrophil count (ANC) ≥ 500 cells/mm^3
  • Creatinine clearance ≥ 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Platelets ≥ 50,000 cells/mm^3
  • Negative serum pregnancy test within one week prior to registration for females of childbearing potential
  • Patients must have received first-line/induction chemotherapy (4 cycles) and achieved stable disease or a partial response
  • Prior systemic chemotherapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted
  • Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable
  • Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT
  • For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation; if the primary disease is found in the peripheral or central lung parenchyma without nodal disease for instance, SBRT may be employed; if primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation
  • If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy
  • Patients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression prior to enrollment

Exclusion Criteria

  • Clinical or radiologic evidence of untreated and/or progressive brain metastases
  • Cutaneous metastasis of NSCLC
  • Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions
  • Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
  • Metastases located within 3 cm of previously irradiated (< 3Gy per fraction) structures if if not a candidate for surgery for these lesions and if:
  • Spinal cord previously irradiated to > 40 Gy
  • Brachial plexus previously irradiated to > 50 Gy
  • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
  • Brainstem previously irradiated to > 50 Gy
  • Lung previously irradiated with prior V20 Gy > 35%
  • Patients receiving targeted therapy (non-cytotoxic systemic therapy) for NSCLC in the first-line setting
  • If a patient has progressed in previous areas of primary disease that received definitive doses of radiation, these patients would require re-irradiation in previous high dose anatomic areas and are not eligible for this study
  • Patients with malignant pleural effusions that do not resolve after first-line systemic therapy; patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line chemotherapy
  • Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 SBRT plans to cover these distinct metastatic disease entities
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Patients who are pregnant or nursing
  • Participation in any investigational drug study (excluding non-oncology and/or symptom management studies) within 4 weeks prior to registration
  • Known human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are 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
  • Patients who received prior non-induction pembrolizumab, patients on chronic steroids or who have active autoimmune disease for which they received systemic treatment in the previous 2 years with corticosteroids, disease modifying agents, or immunosuppressive drugs. Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is allowed. Patients with active interstitial lung disease or who have a history of pneumonitis for which they had received glucocorticoids are not eligible
  • Prior bevacizumab therapy

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm 1 (maintenance chemotherapy) 		Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride PO QD, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Docetaxel
    Given IV
    Other names:
    • Docecad
    • RP56976
    • Taxotere
    • Taxotere Injection Concentrate
  • Drug: Gemcitabine
    Given IV
    Other names:
    • dFdC
    • dFdCyd
    • Difluorodeoxycytidine
  • Drug: Pemetrexed Disodium
    Given IV
    Other names:
    • Alimta
    • LY231514
    • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
  • Drug: Erlotinib Hydrochloride
    Given PO
    Other names:
    • Tarceva
  • Drug: Pembrolizumab
    Given IV
    Other names:
    • Keytruda
Experimental
Arm 2 (SBRT + maintenance chemotherapy) 		Patients undergo LCT over 2-4 weeks. If LCT cannot be used to treat primary disease sites, patients also undergo IMRT or 3DCRT over 3-5 weeks. Within 2 weeks after completion of radiation therapy, patients receive chemotherapy as in Arm 1. Patients may possibly undergo surgery.
  • Radiation: 3-Dimensional Conformal Radiation Therapy (3D-CRT)
    Undergo 3DCRT
    Other names:
    • 3-dimensional conformal radiation therapy
    • 3-dimensional radiation therapy
    • 3D CONFORMAL RADIATION THERAPY
    • 3D CRT
    • 3D-CRT
    • Conformal Therapy
    • Radiation Conformal Therapy
  • Drug: Docetaxel
    Given IV
    Other names:
    • Docecad
    • RP56976
    • Taxotere
    • Taxotere Injection Concentrate
  • Drug: Gemcitabine
    Given IV
    Other names:
    • dFdC
    • dFdCyd
    • Difluorodeoxycytidine
  • Radiation: Intensity-Modulated Radiation Therapy (IMRT)
    Undergo IMRT
    Other names:
    • IMRT
    • Intensity Modulated RT
    • INTENSITY-MODULATED RADIATION THERAPY
    • Intensity-Modulated Radiotherapy
  • Drug: Pemetrexed Disodium
    Given IV
    Other names:
    • Alimta
    • LY231514
    • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    Undergo SBRT
    Other names:
    • SBRT
    • stereotactic body radiation therapy
  • Drug: Erlotinib Hydrochloride
    Given PO
    Other names:
    • Tarceva
  • Drug: Pembrolizumab
    Given IV
    Other names:
    • Keytruda

Recruiting Locations

Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona 85297
Contact:
Site Public Contact
480-922-4600

Arizona Center for Cancer Care-Peoria
Peoria, Arizona 85381
Contact:
Site Public Contact
623-773-2873

Mayo Clinic Hospital
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015

Arizona Breast Cancer Specialists-Scottsdale
Scottsdale, Arizona 85258
Contact:
Site Public Contact
480-922-4600

Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Contact:
Site Public Contact
855-776-0015

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900

Banner University Medical Center - Tucson
Tucson, Arizona 85719
Contact:
Site Public Contact
aselegue@email.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Contact:
Site Public Contact
800-327-2873

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

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

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

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Los Angeles County-USC Medical Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

Saint Joseph Hospital - Orange
Orange, California 92868
Contact:
Site Public Contact
714-734-6220

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

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

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

Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

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

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406

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

Beebe Health Campus
Rehoboth Beach, Delaware 19971
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

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

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015

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

Miami Cancer Institute
Miami, Florida 33176
Contact:
Site Public Contact
786-596-2000

UF Cancer Center at Orlando Health
Orlando, Florida 32806
Contact:
Site Public Contact
321-841-7246
CancerClinicalTrials@orlandohealth.com

Tallahassee Memorial HealthCare
Tallahassee, Florida 32308
Contact:
Site Public Contact
850-431-0673

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
canceranswers@moffitt.org

Cleveland Clinic-Weston
Weston, Florida 33331
Contact:
Site Public Contact
954-659-5705
CancerAnswer@ccf.org

Grady Health System
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
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404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
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404-851-7115

Augusta University Medical Center
Augusta, Georgia 30912
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706-721-2388
ga_cares@augusta.edu

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

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

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Site Public Contact
312-942-5498
clinical_trials@rush.edu

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

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Edward Hines Jr VA Hospital
Hines, Illinois 60141
Contact:
Site Public Contact
708-202-8387

Condell Memorial Hospital
Libertyville, Illinois 60048
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocatehealth.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois 61114
Contact:
Site Public Contact
779-696-9400
cancercare@swedishamerican.org

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

Southwest Illinois Health Services LLP
Swansea, Illinois 62226
Contact:
Site Public Contact
618-236-1000
lynns@thecancercenter.com

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

Parkview Regional Medical Center
Fort Wayne, Indiana 46845
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Site Public Contact
877-784-4673

Community Cancer Center East
Indianapolis, Indiana 46219
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317-497-2823
lcheri@ecommunity.com

Community Cancer Center South
Indianapolis, Indiana 46227
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Site Public Contact
317-497-2823
lcheri@ecommunity.com

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
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317-528-7060

Community Cancer Center North
Indianapolis, Indiana 46256
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317-497-2823
lcheri@ecommunity.com

Franciscan Health Mooresville
Mooresville, Indiana 46158
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317-834-3603

Iowa Methodist Medical Center
Des Moines, Iowa 50309
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515-241-6727

Lawrence Memorial Hospital
Lawrence, Kansas 66044
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316-268-5374
Keisha.humphries@ascension.org

Ascension Via Christi Hospitals Wichita
Wichita, Kansas 67214
Contact:
Site Public Contact
800-362-0070
Keisha.humphries@ascension.org

Saint Elizabeth Medical Center South
Edgewood, Kentucky 41017
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859-301-5473
darla.hehman@stelizabeth.com

Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky 40202
Contact:
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502-629-2500

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
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502-562-3429

LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana 70809
Contact:
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225-215-1353
clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Richard A Henson Cancer Institute at Ocean Pines
Ocean Pines, Maryland 21811
Contact:
Site Public Contact
410-543-7017
stephanie.cason@peninsula.org

Peninsula Regional Medical Center
Salisbury, Maryland 21801
Contact:
Site Public Contact
866-922-6237

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Contact:
Site Public Contact
781-744-8027

McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Flint
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Singh and Arora Hematology Oncology PC
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

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

McLaren-Greater Lansing
Lansing, Michigan 48910
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Mid-Michigan Physicians-Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan 49770
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren-Port Huron
Port Huron, Michigan 48060
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

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

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

Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128
Contact:
Site Public Contact
800-525-1483

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
jrichards@research.pcrmc.com

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Wentworth-Douglass Hospital
Dover, New Hampshire 03820
Contact:
Site Public Contact
603-740-2150

Community Medical Center
Toms River, New Jersey 08755
Contact:
Site Public Contact
732-818-3882

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York 11215
Contact:
Site Public Contact
718-780-3677
Adg9003@nyp.org

Mount Sinai Hospital
New York, New York 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476

Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
Contact:
Site Public Contact
800-804-9376

Atrium Health University City/LCI-University
Charlotte, North Carolina 28262
Contact:
Site Public Contact
800-804-9376

Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
Contact:
Site Public Contact
800-804-9376

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

CarolinaEast Medical Center
New Bern, North Carolina 28561
Contact:
Site Public Contact
252-634-6589
lharrison@carolinaeasthealth.com

NHRMC Radiation Oncology - Supply
Supply, North Carolina 28462
Contact:
Site Public Contact
910-754-4716

New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000

NHRMC Radiation Oncology - 16th Street
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-251-1839

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Cleveland Clinic Akron General
Akron, Ohio 44307
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
sheree@columbusccop.org

University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-558-4553
uchealthnews@uc.edu

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842

University Pointe
West Chester, Ohio 45069
Contact:
Site Public Contact
clinicaltrials@ucphysicians.com

Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Good Samaritan Hospital
Corvallis, Oregon 97330
Contact:
Site Public Contact
541-768-4352
stmock@samhealth.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-955-6084

Aria Health-Torresdale Campus
Philadelphia, Pennsylvania 19114
Contact:
Site Public Contact
215-612-5296

Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania 18840
Contact:
Site Public Contact
800-836-0388

Reading Hospital
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Self Regional Healthcare
Greenwood, South Carolina 29646
Contact:
Site Public Contact
864-725-4771
nmcgaha@selfregional.org

Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina 29926
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Spartanburg Medical Center
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Covenant Medical Center-Lakeside
Lubbock, Texas 79410
Contact:
Site Public Contact
806-725-8000
jaccresearch@covhs.org

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
804-628-1939
mwellons@vcu.edu

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin 54937
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-433-8889
Christy.Gilchrist@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Contact:
Site Public Contact
920-433-8889
Christy.Gilchrist@hshs.org

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Community Memorial Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
866-680-0505

More Details

NCT ID
NCT03137771
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

PRIMARY OBJECTIVES:

Phase II

To evaluate the impact of adding local consolidative therapy (LCT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy.

Phase III

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure.

II. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions.

III. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity.

IV. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage.

V. To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL) VI. To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA).

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM 1 (CHEMOTHERAPY ALONE): ): Patients may receive docetaxel intravenously (IV) over 60 minutes on Day 1, erlotinib hydrochloride orally (PO) once daily (QD), or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM 2 (SBRT AND CHEMOTHERAPY): Patients undergo LCT over 2-4 weeks. If LCT cannot be used to treat primary disease sites, patients also undergo intensity-modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3DCRT) over 3-5 weeks. Within 2 weeks after completion of radiation therapy, patients receive chemotherapy as in Arm 1. Patients may possibly undergo surgery.

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.