Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
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
- Recurrent Non-Small Cell Lung Carcinoma
- Stage IV Non-Small Cell Lung Cancer
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona 85297
Gilbert, Arizona 85297
Contact:
Site Public Contact
480-922-4600
Site Public Contact
480-922-4600
Arizona Center for Cancer Care-Peoria
Peoria, Arizona 85381
Peoria, Arizona 85381
Contact:
Site Public Contact
623-773-2873
Site Public Contact
623-773-2873
Mayo Clinic Hospital
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Arizona Breast Cancer Specialists-Scottsdale
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Contact:
Site Public Contact
480-922-4600
Site Public Contact
480-922-4600
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900
Site Public Contact
520-694-8900
Banner University Medical Center - Tucson
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Berkeley, California 94704
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
UC San Diego Moores Cancer Center
La Jolla, California 92093
La Jolla, California 92093
Los Angeles County-USC Medical Center
Los Angeles, California 90033
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451
Site Public Contact
323-865-0451
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451
Site Public Contact
323-865-0451
Saint Joseph Hospital - Orange
Orange, California 92868
Orange, California 92868
Contact:
Site Public Contact
714-734-6220
Site Public Contact
714-734-6220
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Roseville, California 95678
Sutter Medical Center Sacramento
Sacramento, California 95816
Sacramento, California 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Saint Helena Hospital
Saint Helena, California 94574
Saint Helena, California 94574
Contact:
Site Public Contact
707-967-3698
Site Public Contact
707-967-3698
City of Hope South Pasadena
South Pasadena, California 91030
South Pasadena, California 91030
Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
South San Francisco, California 94080
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450
Site Public Contact
530-582-6450
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406
Site Public Contact
719-365-2406
Yale University
New Haven, Connecticut 06520
New Haven, Connecticut 06520
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UF Cancer Center at Orlando Health
Orlando, Florida 32806
Orlando, Florida 32806
Tallahassee Memorial HealthCare
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Contact:
Site Public Contact
850-431-0673
Site Public Contact
850-431-0673
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Cleveland Clinic-Weston
Weston, Florida 33331
Weston, Florida 33331
Grady Health System
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164
Site Public Contact
404-489-9164
Emory University Hospital Midtown
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447
Site Public Contact
888-946-7447
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868
Site Public Contact
404-778-1868
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Savannah, Georgia 31405
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Edward Hines Jr VA Hospital
Hines, Illinois 60141
Hines, Illinois 60141
Contact:
Site Public Contact
708-202-8387
Site Public Contact
708-202-8387
Condell Memorial Hospital
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357
Site Public Contact
708-226-4357
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
OSF Saint Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528
Site Public Contact
217-788-3528
Southwest Illinois Health Services LLP
Swansea, Illinois 62226
Swansea, Illinois 62226
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Parkview Regional Medical Center
Fort Wayne, Indiana 46845
Fort Wayne, Indiana 46845
Contact:
Site Public Contact
877-784-4673
Site Public Contact
877-784-4673
Goshen Center for Cancer Care
Goshen, Indiana 46526
Goshen, Indiana 46526
Community Cancer Center East
Indianapolis, Indiana 46219
Indianapolis, Indiana 46219
Community Cancer Center South
Indianapolis, Indiana 46227
Indianapolis, Indiana 46227
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060
Site Public Contact
317-528-7060
Community Cancer Center North
Indianapolis, Indiana 46256
Indianapolis, Indiana 46256
Franciscan Health Mooresville
Mooresville, Indiana 46158
Mooresville, Indiana 46158
Contact:
Site Public Contact
317-834-3603
Site Public Contact
317-834-3603
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
Lawrence Memorial Hospital
Lawrence, Kansas 66044
Lawrence, Kansas 66044
Via Christi Regional Medical Center
Wichita, Kansas 67214
Wichita, Kansas 67214
Saint Elizabeth Medical Center South
Edgewood, Kentucky 41017
Edgewood, Kentucky 41017
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-629-2500
Site Public Contact
502-629-2500
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429
Site Public Contact
502-562-3429
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823
Site Public Contact
800-888-8823
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300
Site Public Contact
443-546-1300
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100
Site Public Contact
410-553-8100
Richard A Henson Cancer Institute at Ocean Pines
Ocean Pines, Maryland 21811
Ocean Pines, Maryland 21811
Peninsula Regional Medical Center
Salisbury, Maryland 21801
Salisbury, Maryland 21801
Contact:
Site Public Contact
866-922-6237
Site Public Contact
866-922-6237
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265
Site Public Contact
617-638-8265
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
Contact:
Site Public Contact
781-744-8027
Site Public Contact
781-744-8027
McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Bay City, Michigan 48706
McLaren Cancer Institute-Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Clinton Township, Michigan 48038
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
McLaren Cancer Institute-Flint
Flint, Michigan 48532
Flint, Michigan 48532
Singh and Arora Hematology Oncology PC
Flint, Michigan 48532
Flint, Michigan 48532
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
McLaren-Greater Lansing
Lansing, Michigan 48910
Lansing, Michigan 48910
Mid-Michigan Physicians-Lansing
Lansing, Michigan 48912
Lansing, Michigan 48912
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Mount Clemens, Michigan 48043
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan 49770
Petoskey, Michigan 49770
McLaren-Port Huron
Port Huron, Michigan 48060
Port Huron, Michigan 48060
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Saint Luke's Hospital of Duluth
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128
Kansas City, Missouri 64128
Contact:
Site Public Contact
800-525-1483
Site Public Contact
800-525-1483
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell Regional Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Renown Regional Medical Center
Reno, Nevada 89502
Reno, Nevada 89502
Wentworth-Douglass Hospital
Dover, New Hampshire 03820
Dover, New Hampshire 03820
Contact:
Site Public Contact
603-740-2150
Site Public Contact
603-740-2150
Community Medical Center
Toms River, New Jersey 08755
Toms River, New Jersey 08755
Contact:
Site Public Contact
732-818-3882
Site Public Contact
732-818-3882
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Bronx, New York 10467
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York 11215
Brooklyn, New York 11215
Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Stony Brook University Medical Center
Stony Brook, New York 11794
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215
Site Public Contact
800-862-2215
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
Atrium Health University City/LCI-University
Charlotte, North Carolina 28262
Charlotte, North Carolina 28262
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
Concord, North Carolina 28025
Contact:
Site Public Contact
704-403-1520
Site Public Contact
704-403-1520
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
CarolinaEast Medical Center
New Bern, North Carolina 28561
New Bern, North Carolina 28561
NHRMC Radiation Oncology - Supply
Supply, North Carolina 28462
Supply, North Carolina 28462
Contact:
Site Public Contact
910-754-4716
Site Public Contact
910-754-4716
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000
Site Public Contact
910-342-3000
NHRMC Radiation Oncology - 16th Street
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-251-1839
Site Public Contact
910-251-1839
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Cleveland Clinic Akron General
Akron, Ohio 44307
Akron, Ohio 44307
Adena Regional Medical Center
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Cleveland, Ohio 44111
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
The Mark H Zangmeister Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Mansfield, Ohio 44906
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
North Coast Cancer Care
Sandusky, Ohio 44870
Sandusky, Ohio 44870
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Wooster, Ohio 44691
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402
Site Public Contact
405-752-3402
Good Samaritan Hospital
Corvallis, Oregon 97330
Corvallis, Oregon 97330
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Bryn Mawr, Pennsylvania 19010
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Harrisburg, Pennsylvania 17109
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Paoli, Pennsylvania 19301
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-955-6084
Site Public Contact
215-955-6084
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19114
Contact:
Site Public Contact
215-612-5296
Site Public Contact
215-612-5296
Reading Hospital
West Reading, Pennsylvania 19611
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323
Site Public Contact
610-988-9323
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Self Regional Healthcare
Greenwood, South Carolina 29646
Greenwood, South Carolina 29646
Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
Greer, South Carolina 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Greer, South Carolina 29651
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina 29926
Hilton Head Island, South Carolina 29926
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Seneca, South Carolina 29672
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Spartanburg, South Carolina 29307
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Memphis, Tennessee 38120
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
M D Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Covenant Medical Center-Lakeside
Lubbock, Texas 79410
Lubbock, Texas 79410
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
West Virginia University Healthcare
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin 54937
Fond Du Lac, Wisconsin 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Aurora Bay Area Medical Group-Marinette
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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.