Maintenance Chemotherapy with or without Local Consolidative Therapy in Treating Patients with Stage IV Non-small Cell Lung Cancer

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This clinical trial matches:
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Status: Active

Description

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.

Eligibility Criteria

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 trialtreatment on this study 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 by a radiation oncologist (and a surgeon if surgery is planned) within 30 days prior to registration * Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least diagnostic quality computed tomography (CT) chest through the adrenals or positron emission tomography (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 x upper limit of normal (ULN) or =< 5 x ULN with metastatic liver disease within 14 days prior to registration.
  • Total bilirubin =< 1.5 x ULN within 14 days prior to registration.
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L within 14 days prior to registration.
  • Platelets >= 100 x 10^9/L within 14 days prior to registration.
  • Negative serum pregnancy test within 30 days prior to registration for females of childbearing potential.
  • Patients must have received first-line/induction systemic therapy comprising of immunotherapy and/or platinum-based chemotherapy (a total of 4 cycles or courses), and achieved stable disease or a partial response.
  • Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, adjuvant therapy for stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted.
  • Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to stereotactic body radiation therapy (SBRT) or resection (at least one disease site must be amenable to radiation); some examples of what constitutes specific radiation treatment sites defining distinct metastatic disease sites are as follows: a) A lesion in each adrenal gland represents 2 of 3 sites of metastatic disease allowed to be treated on protocol; b) Similarly to NRG study RTOG 0631, disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment; and c) Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment.
  • 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 at the discretion of the treating institution. 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; surgery should only be used for metastatic tumors that can be completely resected by lobectomy, segmentectomy, or wide wedge resection.
  • 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.
  • Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable.
  • Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression within 30 days prior to enrollment.
  • At least one site of metastatic disease or primary disease must be determined by radiation oncologist to be treatable with radiation.
  • Subjects may receive palliative radiotherapy for symptomatic metastases prior to enrollment provided that there is at least one other non-irradiated lesion amenable to LCT at the time of enrollment.

Exclusion Criteria

  • Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy.
  • 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 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, non-immunotherapy based systemic therapy) for NSCLC in the first-line setting. Such designations would include but not be limited to treatments targeting EGFR mutant positive or ALK positive 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 systemic therapy.
  • Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 radiation/surgery plans to cover these distinct metastatic disease entities.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 180 days after the completion of all treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding are also excluded.
  • 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 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; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Patients who received prior 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 is excluded.

Locations & Contacts

Arizona

Gilbert
Arizona Breast Cancer Specialists-Gilbert
Status: Active
Contact: Christopher Alan Biggs
Phone: 480-922-4600
Peoria
Arizona Center for Cancer Care-Peoria
Status: Active
Contact: Christopher Alan Biggs
Phone: 623-773-2873
Phoenix
Mayo Clinic Hospital
Status: Active
Name Not Available
Phone: 855-776-0015
Scottsdale
Arizona Breast Cancer Specialists-Scottsdale
Status: Active
Contact: Christopher Alan Biggs
Phone: 480-922-4600
Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Charles Chia-Chuen Hsu
Phone: 520-626-9008
University of Arizona Cancer Center-Orange Grove Campus
Status: Active
Contact: Charles Chia-Chuen Hsu
Phone: 520-694-8900

Arkansas

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

California

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Christopher Uwe Jones
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Sagus Sampath
Phone: 800-826-4673 Email: becomingapatient@coh.org
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: James John Urbanic
Phone: 858-822-5354 Email: cancercto@ucsd.edu
Los Angeles
Los Angeles County-USC Medical Center
Status: Active
Contact: Jason Chao Ye
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Jason Chao Ye
Phone: 323-865-0451
Orange
Saint Joseph Hospital - Orange
Status: Active
Contact: Robert B. Ash
Phone: 714-734-6220
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Samantha Andrews Seaward
Phone: 510-891-3400
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Christopher Uwe Jones
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Megan Eileen Daly
Phone: 916-734-3089
Saint Helena
Saint Helena Hospital
Status: Active
Contact: Gregory B. Smith
Phone: 707-967-3698
South Pasadena
City of Hope South Pasadena
Status: Active
Contact: Sagus Sampath
Phone: 800-826-4673 Email: becomingapatient@coh.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: Active
Contact: Samantha Andrews Seaward
Phone: 510-891-3400
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Active
Contact: Megan Eileen Daly
Phone: 530-582-6450

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
UCHealth Memorial Hospital Central
Status: Active
Contact: Anthony David Elias
Phone: 719-365-2406
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Anthony David Elias
Phone: 970-297-6150

Connecticut

New Haven
Yale University
Status: Active
Contact: Roy H. Decker
Phone: 203-785-5702 Email: canceranswers@yale.edu

Delaware

Newark
Helen F Graham Cancer Center
Status: Active
Contact: Gregory Andrew Masters
Phone: 302-623-4450 Email: KDempsey@christianacare.org

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Anamaria R. Yeung
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Jacksonville
Mayo Clinic in Florida
Status: Active
Contact: Helen J Ross
Phone: 855-776-0015
Tallahassee
Tallahassee Memorial HealthCare
Status: Active
Contact: Karen Bullock Russell
Phone: 850-431-5566 Email: Theresa.Shannon@tmh.org
Weston
Cleveland Clinic-Weston
Status: Active
Contact: Gregory M. M. Videtic
Phone: 954-659-5705

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Active
Contact: Kristin Ann Higgins
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Kristin Ann Higgins
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Active
Contact: Kristin Ann Higgins
Phone: 888-946-7447
Grady Health System
Status: Active
Contact: Kristin Ann Higgins
Phone: 404-489-9164
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Howard A. Zaren
Phone: 412-339-5294 Email: Roster@nrgoncology.org

Hawaii

Honolulu
Queen's Medical Center
Status: Active
Contact: Kenneth N.M. Sumida
Phone: 412-339-5294 Email: Roster@nrgoncology.org
The Cancer Center of Hawaii-Liliha
Status: Active
Contact: Kenneth N.M. Sumida
Phone: 808-547-6881

Illinois

Chicago
Northwestern University
Status: Active
Contact: Timothy Joseph Kruser
Phone: 312-695-1301 Email: cancer@northwestern.edu
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Peoria
OSF Saint Francis Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 217-788-3528
Swansea
Southwest Illinois Health Services LLP
Status: Active
Contact: Bryan A. Faller
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Urbana
Carle Cancer Center
Status: Active
Contact: Daniel Hull Barnett
Phone: 800-446-5532 Email: Research@carle.com

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: Active
Contact: Brian K. Chang
Phone: 260-373-8888 Email: parkviewresearch@parkview.com
Indianapolis
Franciscan Health Indianapolis
Status: Active
Contact: Michael Scott-Soon Eaton
Phone: 317-528-7060

Iowa

Des Moines
Iowa Methodist Medical Center
Status: Active
Contact: Robert J. Behrens
Phone: 515-241-6727

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Fen Wang
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Fen Wang
Phone: 913-945-7552 Email: ctnursenav@kumc.edu
Wichita
Via Christi Regional Medical Center
Status: Active
Contact: Pavan S. Reddy
Phone: 800-362-0070 Email: Keisha.humphries@ascension.org

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Neal E. Dunlap
Phone: 502-562-3429

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Pranshu Mohindra
Phone: 800-888-8823
Columbia
Central Maryland Radiation Oncology in Howard County
Status: Active
Contact: Pranshu Mohindra
Phone: 443-546-1300
Glen Burnie
Tate Cancer Center
Status: Active
Contact: Pranshu Mohindra
Phone: 410-553-8100
Salisbury
Peninsula Regional Medical Center
Status: Active
Contact: John Romeo Mansueti
Phone: 866-922-6237

Massachusetts

Boston
Boston Medical Center
Status: Active
Contact: Kimberley S. Mak
Phone: 617-638-8265
Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Paul Joseph Hesketh
Phone: 781-744-8027

Michigan

Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Eleanor M. Walker
Phone: 313-916-1784
Detroit
Henry Ford Hospital
Status: Active
Contact: Eleanor M. Walker
Phone: 313-916-1784
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Bemidji
Sanford Clinic North-Bemidgi
Status: Active
Contact: Preston D. Steen
Phone: 218-333-5000
Duluth
Saint Luke's Hospital of Duluth
Status: Active
Contact: Steven R. Bonin
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Saint Paul
Regions Hospital
Status: Active
Contact: Paul W. Sperduto
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

Missouri

Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Jay W. Carlson
Phone: 314-251-6770
Missouri Baptist Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Washington University School of Medicine
Status: Active
Contact: Clifford G. Robinson
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Montana

Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Nebraska

Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Nevada

Reno
Renown Regional Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org

New Hampshire

Dover
Wentworth-Douglass Hospital
Status: Active
Contact: Arul Mahadevan
Phone: 603-740-2150

New Jersey

Mount Holly
Virtua Memorial
Status: Active
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762
Voorhees
Virtua Voorhees
Status: Active
Contact: Lemuel S. Ariaratnam
Phone: 856-247-7395

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: Active
Contact: Gregory N. Gan
Phone: 505-272-0530 Email: AYost@nmcca.org
Lovelace Radiation Oncology
Status: Temporarily closed to accrual
Contact: Gregory N. Gan
Phone: 505-272-0530 Email: AYost@nmcca.org
University of New Mexico Cancer Center
Status: Active
Contact: Gregory N. Gan
Phone: 505-925-0366 Email: LByatt@nmcca.org
Santa Fe
Christus Saint Vincent Regional Cancer Center
Status: Active
Contact: Gregory N. Gan
Phone: 505-913-8933 Email: Olivia.Sloan@nmcancercare.com

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Nitin Ohri
Phone: 718-904-2730 Email: aecc@aecom.yu.edu
Montefiore Medical Center-Einstein Campus
Status: Active
Name Not Available
Phone: 718-379-6866 Email: aaraiza@montefiore.org
New York
Mount Sinai Hospital
Status: Active
Contact: Kenneth E. Rosenzweig
Phone: 212-824-7309 Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Yuhchyau Chen
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Craig Eli Grossman
Phone: 800-862-2215
White Plains
Dickstein Cancer Treatment Center
Status: Active
Contact: Jeffrey M. Vainshtein
Phone: 914-849-7582 Email: mcortese@wphospital.org

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: Thomas E. Stinchcombe
Phone: 888-275-3853
Supply
NHRMC Radiation Oncology - Supply
Status: Active
Contact: Michael A. Papagikos
Phone: 910-754-4716
Wilmington
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: Active
Contact: Michael A. Papagikos
Phone: 910-342-3000
NHRMC Radiation Oncology - 16th Street
Status: Active
Contact: Michael A. Papagikos
Phone: 910-251-1839

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Preston D. Steen
Phone: 701-323-5760 Email: tamara.fischer@sanfordhealth.org
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Preston D. Steen
Phone: 701-234-6161

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Mitchel L. Fromm
Phone: 330-344-6348
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Kevin Patrick Redmond
Phone: 513-558-4553 Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Mitchell Machtay
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Active
Contact: Gregory M. M. Videtic
Phone: 216-476-9362
Cleveland Clinic Foundation
Status: Active
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Jose Gilberto Bazan
Phone: 800-293-5066 Email: Jamesline@osumc.edu
The Mark H Zangmeister Center
Status: Active
Contact: Timothy David Moore
Phone: 614-488-2118 Email: sheree@columbusccop.org
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: Active
Contact: Gregory M. M. Videtic
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Active
Contact: Gregory M. M. Videtic
Phone: 440-312-4293 Email: hugneyc@cchseast.org
Sandusky
North Coast Cancer Care
Status: Active
Contact: Gregory M. M. Videtic
Phone: 412-339-5294 Email: Roster@nrgoncology.org
West Chester
University Pointe
Status: Active
Contact: Kevin Patrick Redmond Email: clinicaltrials@ucphysicians.com

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: Active
Contact: Jay W. Carlson
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: Active
Contact: J. Spencer Thompson
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Active
Contact: Andrew Y. Kee
Phone: 800-220-4937 Email: cancer@lhs.org
Providence Portland Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Albert S. DeNittis
Phone: 484-476-2649 Email: turzoe@mlhs.org
Drexel Hill
Delaware County Memorial Hospital
Status: Active
Contact: Rachelle M. Lanciano
Phone: 610-284-8237 Email: jolene.garney@crozer.org
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: Active
Contact: Timothy Francis Burns
Phone: 717-724-6765 Email: klitchfield@PINNACLEHEALTH.org
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Name Not Available
Phone: 570-374-8555 Email: HemonCCTrials@geisinger.edu
Philadelphia
NRG Oncology
Status: Active
Contact: Puneeth Iyengar
Phone: 214-648-7097 Email: puneeth.iyengar@utsouthwestern.edu
Thomas Jefferson University Hospital
Status: Active
Contact: Bo Lu
Phone: 215-955-6084
West Reading
Reading Hospital
Status: Active
Contact: Terrence Paul Cescon
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Fiori Alite
Phone: 570-271-5251 Email: HemonCCTrials@geisinger.edu
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Albert S. DeNittis
Phone: 484-476-2649 Email: turzoe@mlhs.org

South Carolina

Greenville
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251 Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251 Email: kwilliams8@ghs.org
Greenwood
Self Regional Healthcare
Status: Active
Contact: Carolyn Dolores Britten
Phone: 864-725-4771 Email: nmcgaha@selfregional.org
Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Patricia C. Griffin
Phone: 864-560-6104 Email: kmertz-rivera@gibbscc.org
Hilton Head Island
The Radiation Oncology Center-Hilton Head / Bluffton
Status: Active
Contact: Howard A. Zaren
Phone: 912-819-5704 Email: underberga@sjchs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251 Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251 Email: kwilliams8@ghs.org
Spartanburg Medical Center
Status: Active
Contact: Patricia C. Griffin
Phone: 864-560-6104 Email: kmertz-rivera@gibbscc.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Preston D. Steen
Phone: 605-312-3320 Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: Active
Contact: Raymond Uyiosa Osarogiagbon
Phone: 901-226-3077

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Puneeth Iyengar
Phone: 214-648-7097
Galveston
University of Texas Medical Branch
Status: Active
Contact: Todd Allen Swanson
Phone: 409-772-1950 Email: clinical.research@utmb.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Daniel Gomez
Phone: 713-792-3245
San Antonio
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Ying Li
Phone: 210-450-3800 Email: CTO@uthscsa.edu

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Malcolm David Mattes
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: Active
Contact: Ellen L. Ziaja
Phone: 414-302-2304 Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Ellen L. Ziaja
Phone: 414-302-2304 Email: ncorp@aurora.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Collin D. Driscoll
Phone: 608-775-2385 Email: cancerctr@gundersenhealth.org
Marinette
Aurora Bay Area Medical Group-Marinette
Status: Active
Contact: Ellen L. Ziaja
Phone: 414-302-2304 Email: ncorp@aurora.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: Active
Contact: Ellen L. Ziaja
Phone: 412-339-5294 Email: Roster@nrgoncology.org
Aurora Sinai Medical Center
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Ellen L. Ziaja
Phone: 414-302-2304 Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Ellen L. Ziaja
Phone: 414-302-2304 Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Ellen L. Ziaja
Phone: 414-302-2304 Email: ncorp@aurora.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Name Not Available
Phone: 414-302-2304 Email: ncorp@aurora.org

Ontario

London
London Regional Cancer Program
Status: Active
Contact: Alexander V. Louie
Phone: 519-685-8600
Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Active
Name Not Available
Phone: 613-761-4395

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: Active
Name Not Available
Phone: 011-966-1-464-7272 ext 38005

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate the impact of adding LCT (local consolidation therapy) 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 II)

II. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall 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)

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 maintain 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 deoxyribonucleic acid (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.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Puneeth Iyengar

Trial IDs

Primary ID NRG-LU002
Secondary IDs NCI-2016-00849
Clinicaltrials.gov ID NCT03137771