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Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients with Stage III Non-small Cell Lung Cancer

Trial Status: Administratively Complete

This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.

Inclusion Criteria

  • Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC
  • Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)
  • Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable; patients with T4, any N are eligible
  • Patients must have measurable disease, i.e., lesions that can be accurately measured in at least 1 dimension (longest dimension in the plane of measurement is to be recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm)
  • Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
  • If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible
  • The institution’s pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments (CLIA) certified lab documents presence of known “sensitive” mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon 19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement; either the primary tumor or the metastatic lymph node tissue may be used for testing of mutations
  • The institution’s pre-enrollment biomarker screening at a CLIA certified lab documents absence of T790M mutation in the EGFR TK domain
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: * History/physical examination, including recording of pulse, blood pressure (BP), weight, and body surface area, within 45 days prior to registration * Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to mid-thighs) within 30 days prior to registration; PET/CT must be negative for distant metastasis * CT scan with contrast of the chest and upper abdomen to include liver and adrenals (unless medically contraindicated) within 30 days prior to registration * Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with contrast, if MRI medically contraindicated) within 30 days prior to registration
  • Zubrod performance status 0-1 within 14 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registration
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) within 14 days prior to registration
  • Bilirubin within normal institutional limits within 14 days prior to registration
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Patient must provide study specific informed consent prior to study entry, including consent for mandatory screening of tissue

Exclusion Criteria

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Atelectasis of the entire lung
  • Contralateral hilar node involvement
  • Exudative, bloody, or cytologically malignant effusions
  • Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael Christian Dobelbower
Phone: 800-828-8816

Alaska

Anchorage
Providence Alaska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871

Arizona

Gilbert
Banner MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Daniel Dean Chamberlain
Phone: 602-747-9738
Phoenix
Mayo Clinic Hospital in Arizona
Status: ADMINISTRATIVELY_COMPLETE
Contact: Ramaswamy Govindan
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
Contact: Yolanda I. Garces
Phone: 855-776-0015

California

Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Megan Eileen Daly
Phone: 661-323-4673
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Loren K. Mell
Phone: 858-822-5354
Marysville
Fremont - Rideout Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Megan Eileen Daly
Phone: 530-749-4400
Merced
Mercy UC Davis Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Parminder S. Sidhu
Phone: 209-564-3600
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
Contact: Billy W. Loo
Phone: 650-498-7061
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Megan Eileen Daly
Phone: 916-734-3089
Saint Helena
Saint Helena Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David John Tate
Phone: 707-967-3698
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Sue Sun Yom
Phone: 877-827-3222
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Megan Eileen Daly
Phone: 530-582-6450

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Brian Dennis Kavanagh
Phone: 720-848-0650
Boulder
Rocky Mountain Cancer Centers-Boulder
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Colorado Springs
Penrose-Saint Francis Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 303-777-2663
UCHealth Memorial Hospital Central
Status: CLOSED_TO_ACCRUAL
Contact: Jane Witter Ridings
Phone: 719-365-2406
Fort Collins
Poudre Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Brian Dennis Kavanagh
Phone: 970-297-6150
Greeley
North Colorado Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663

Connecticut

Hartford
Hartford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Neal B. Goldberg
Phone: 860-545-5363
New Britain
The Hospital of Central Connecticut
Status: CLOSED_TO_ACCRUAL
Contact: Neal B. Goldberg
Phone: 860-224-5660

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Adam Raben
Phone: 302-733-6227

Florida

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: CLOSED_TO_ACCRUAL
Contact: Adrian Shea Ishkanian
Phone: 305-243-2647
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ignacio Castellon
Phone: 954-265-4325
Jacksonville
Baptist MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark Emerson Augspurger
Phone: 904-202-7051
Baptist Medical Center South
Status: CLOSED_TO_ACCRUAL
Contact: Mark Emerson Augspurger
Phone: 904-202-7027
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Adrian Shea Ishkanian
Phone: 305-243-2647
Orlando
Orlando Health Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Justin M Rineer
Phone: 321-841-7246
Palatka
Cancer Center of Putnam
Status: CLOSED_TO_ACCRUAL
Contact: Mark Emerson Augspurger
Phone: 904-202-7051
Pembroke Pines
Memorial Hospital West
Status: CLOSED_TO_ACCRUAL
Contact: Ignacio Castellon
Phone: 954-265-4325
Saint Augustine
Integrated Community Oncology Network-Flager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark Emerson Augspurger
Phone: 904-202-7051
Stuart
Robert and Carol Weissman Cancer Center at Martin Health
Status: CLOSED_TO_ACCRUAL
Contact: Jorge G. Castillo-Perez
Phone: 772-288-5858ext4
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Thomas Jonathan Dilling
Phone: 800-456-7121

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kristin Ann Higgins
Phone: 412-339-5294
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Kristin Ann Higgins
Phone: 404-778-1868
Emory University Hospital Midtown
Status: CLOSED_TO_ACCRUAL
Contact: Kristin Ann Higgins
Phone: 888-946-7447
Gainesville
Northeast Georgia Medical Center-Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: Frank Greer Lake
Phone: 770-219-8800
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: CLOSED_TO_ACCRUAL
Contact: John A. Pablo
Phone: 412-339-5294

Hawaii

Honolulu
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul Arthur DeMare
Phone: 412-339-5294
The Cancer Center of Hawaii-Liliha
Status: CLOSED_TO_ACCRUAL
Contact: Paul Arthur DeMare
Phone: 412-339-5294

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Nisha A. Mohindra
Phone: 312-695-1301
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Victoria Meucci Villaflor
Phone: 773-834-7424
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Matthew Koshy
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-6601
Effingham
Crossroads Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-342-2066
Elk Grove Village
AMITA Health Alexian Brothers Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Martin J. Boyer
Phone: 847-952-7164
Elmhurst
Elmhurst Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Maria I. Quejada
Phone: 630-758-5460
Hinsdale
AMITA Health Cancer Institute and Outpatient Center
Status: CLOSED_TO_ACCRUAL
Contact: Kapila Kalakota
Phone: 630-286-5500
Maywood
Loyola University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Matthew M. Harkenrider
Phone: 708-226-4357
Naperville
Edward Hospital / Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Maria I. Quejada
Phone: 630-646-6075
Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: CLOSED_TO_ACCRUAL
Contact: Maria I. Quejada
Phone: 630-646-6075
Rockford
SwedishAmerican Regional Cancer Center / ACT
Status: CLOSED_TO_ACCRUAL
Contact: Harvey E. Einhorn
Phone: 779-696-9400
Springfield
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-788-4233

Indiana

Anderson
Saint Vincent Anderson Regional Hospital / Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alexander M. Yeh
Phone: 317-338-2194
Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 260-373-8888
Radiation Oncology Associates PC
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 877-437-2408

Iowa

Ames
McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Joseph James Merchant
Phone: 515-239-2621
Cedar Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Deborah Weil Wilbur
Phone: 319-365-4673
Saint Luke's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nagendra (Bobby) Sai Koneru
Phone: 412-339-5294
Sioux City
Siouxland Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Donald B. Wender
Phone: 712-252-0088

Maine

Augusta
Harold Alfond Center for Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Thomas H. Openshaw
Phone: 207-626-4855
Scarborough
Maine Medical Center- Scarborough Campus
Status: CLOSED_TO_ACCRUAL
Contact: Matthew D. Cheney
Phone: 207-396-8090

Maryland

Baltimore
Sinai Hospital of Baltimore
Status: CLOSED_TO_ACCRUAL
Contact: Jeanette A.F. Linder
Phone: 410-601-6120
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Pranshu Mohindra
Phone: 800-888-8823

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Geoffrey R Oxnard
Phone: 617-667-9925
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Geoffrey R Oxnard
Phone: 877-442-3324
Tufts Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathryn E. Huber
Phone: 617-636-5000
Burlington
Lahey Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Krishna Soujanya Gunturu
Phone: 781-744-8027
Lowell
Lowell General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Blair Ardman
Phone: 978-788-7084

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Dearborn
Beaumont Hospital - Dearborn
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 313-593-8090
Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 412-339-5294
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Kalamazoo
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Livonia
Saint Mary Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Pontiac
Saint Joseph Mercy Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Saginaw
Ascension Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 412-339-5294

Minnesota

Coon Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Duluth
Miller-Dwan Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bret E.B. Friday
Phone: 888-203-7267
Fridley
Unity Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Hennepin County Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Yolanda I. Garces
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517

Missouri

Cape Girardeau
Southeast Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ramaswamy Govindan
Phone: 800-600-3606
Kansas City
Saint Luke's Hospital of Kansas City
Status: CLOSED_TO_ACCRUAL
Contact: Rakesh Gaur
Phone: 888-823-5923
Rolla
Delbert Day Cancer Institute at PCRMC
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 573-202-9950
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 314-251-6770
Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 800-392-0936
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Ramaswamy Govindan
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532

Nebraska

Omaha
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Tien-Shew William Huang
Phone: 402-354-5144

New Hampshire

Concord
Concord Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bryan P. Rowe
Phone: 800-441-1138
Manchester
Elliot Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Brian Knab
Phone: 603-663-1800

New Jersey

Mount Holly
Virtua Memorial
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL
Contact: Salma K. Jabbour
Phone: 732-235-8675
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Salma K. Jabbour
Phone: 732-235-8675
Toms River
Community Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: David J. D'Ambrosio
Phone: 732-818-3882
Voorhees
Virtua Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 856-247-7395

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Thomas McNeil Schroeder
Phone: 505-925-0366

New York

Cooperstown
Mary Imogene Bassett Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Joy E. Anderson
Phone: 607-547-3073
New York
Mount Sinai Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jorge E. Gomez
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai Union Square
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin P. Levy
Phone: 202-243-2373
NYP / Weill Cornell Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Ronald James Scheff
Phone: 212-746-1848
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Yuhchyau Chen
Phone: 585-275-5830
Staten Island
Staten Island University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Alexander Bershadskiy
Phone: 718-226-8888
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Stephen L. Graziano
Phone: 315-464-5476

North Carolina

Asheville
Messino Cancer Centers
Status: CLOSED_TO_ACCRUAL
Contact: Christopher H. Chay
Phone: 800-506-2550
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Christopher H. Chay
Phone: 828-213-4150
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Charles S. Kuzma
Phone: 910-715-2200
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Brian Edward Lally
Phone: 336-713-6771

Ohio

Akron
Cleveland Clinic Akron General
Status: CLOSED_TO_ACCRUAL
Contact: Mitchel L. Fromm
Phone: 330-344-6348
Summa Health System - Akron Campus
Status: CLOSED_TO_ACCRUAL
Contact: Desiree E. Doncals
Phone: 330-375-6101
Barberton
Summa Health System - Barberton Campus
Status: CLOSED_TO_ACCRUAL
Contact: Desiree E. Doncals
Phone: 330-615-4132
Chillicothe
Adena Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 877-779-7585
Cleveland
Case Western Reserve University
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Cleveland Clinic Cancer Center / Fairview Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 216-476-9362
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Columbus
Grant Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-566-4475
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Meng Xu Welliver
Phone: 800-293-5066
The Mark H Zangmeister Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 412-339-5294
Elyria
Mercy Cancer Center-Elyria
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Independence
Cleveland Clinic Cancer Center Independence
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 800-544-6333
Sandusky
North Coast Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 412-339-5294
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 412-339-5294
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 800-862-7798

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Terence S. Herman
Phone: 405-271-8777
Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Charles E. Stewart
Phone: 888-823-5923

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614
Gresham
Legacy Mount Hood Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Y. Kee
Phone: 855-776-0015
Portland
Kaiser Permanente Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Sandeep Hashmukh Mashru
Phone: 503-335-2400
Legacy Good Samaritan Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Y. Kee
Phone: 855-776-0015
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614
Salem
Salem Hospital
Status: CLOSED_TO_ACCRUAL
Contact: John Strother
Phone: 503-561-2618

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Albert S. DeNittis
Phone: 484-476-2649
Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Fiori Alite
Phone: 570-271-5251
Paoli
Paoli Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Albert S. DeNittis
Phone: 484-476-2649
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark Andrew Hallman
Phone: 215-728-4790
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bradley Walter Lash
Phone: 610-402-2273
Wynnewood
Lankenau Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Albert S. DeNittis
Phone: 484-476-2649

South Carolina

Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Carol A. Sherman
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-679-3966
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenwood
Self Regional Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Joanna K. Metzner-Sadurski
Phone: 864-725-4771
Greer
Gibbs Cancer Center-Pelham
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 412-339-5294
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 800-486-5941

Texas

Amarillo
The Don and Sybil Harrington Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Daniel Arsenault
Phone: 806-212-1985
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Hak Choy
Phone: 214-648-7097
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Anne S. Tsao
Phone: 713-792-3245
Lubbock
Covenant Medical Center-Lakeside
Status: CLOSED_TO_ACCRUAL
Contact: Paul J. Anderson
Phone: 806-725-8000

Utah

Murray
Intermountain Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: George M. Cannon
Phone: 801-507-3950
Saint George
Dixie Medical Center Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: George M. Cannon
Phone: 435-688-4167

Washington

Longview
PeaceHealth Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 360-514-2016
Vancouver
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 360-514-3940

West Virginia

Huntington
Edwards Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Maria Rosalia B. Tria Tirona
Phone: 304-399-6617

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 412-339-5294
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 262-257-5100
Mequon
Ascension Columbia Saint Mary's Hospital Ozaukee
Status: CLOSED_TO_ACCRUAL
Contact: Craig Allan Schulz
Phone: 412-339-5294
Milwaukee
Ascension Columbia Saint Mary's Hospital - Milwaukee
Status: CLOSED_TO_ACCRUAL
Contact: Craig Allan Schulz
Phone: 412-339-5294
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 414-805-4380
New Richmond
Cancer Center of Western Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Waukesha
ProHealth Waukesha Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wingate F. Clapper
Phone: 262-928-7632
West Bend
Froedtert West Bend Hospital / Kraemer Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 866-680-0505

PRIMARY OBJECTIVES:

I. To assess whether patients with unresectable local-regionally advanced non-small cell lung cancer (NSCLC) treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone.

SECONDARY OBJECTIVES:

I. To evaluate response rate.

II. To assess toxicity.

III. To assess overall survival.

IV. To correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I (induction therapy): Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.

ARM III (induction therapy): Patients receive crizotinib PO twice daily (BID) for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.

ARMS II AND IV (concurrent chemoradiation): Patients receive concurrent chemotherapy with thoracic radiation therapy beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

CHEMORADIATION: In all treatment arms, patients undergo concurrent intensity modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3-D CRT) QD 5 days a week for 6 weeks. Patients receive 1 of 2 chemotherapy regimens based on the discretion of the treating physician. Patients receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Some patients receive paclitaxel IV and carboplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy for 6 weeks. Two courses of consolidation treatment will begin 4-6 weeks after completion of radiation therapy with paclitaxel IV on days 1 and 22 and carboplatin IV on days 1 and 22 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 2 months, 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Ramaswamy Govindan

  • Primary ID RTOG-1306
  • Secondary IDs NCI-2013-00737
  • Clinicaltrials.gov ID NCT01822496