Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

May 30, 2019 updated by: National Cancer Institute (NCI)

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.

II. To evaluate the additional response rate as a result of sunitinib in this setting.

III. To assess the impact of sunitinib on overall survival compared to the placebo arm.

IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13).

V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Study Type

Interventional

Enrollment (Actual)

210

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Anniston, Alabama, United States, 36202
    - Northeast Alabama Regional Medical Center
  - Mobile, Alabama, United States, 36608
    - Providence Hospital
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, United States, 72205
    - Veteran's Administration Medical Center
- California
  - Anaheim, California, United States, 92806
    - Kaiser Permanente-Anaheim
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Permanente-Bellflower
  - Castro Valley, California, United States, 94546
    - Eden Hospital Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants-Castro Valley
  - Chico, California, United States, 95928
    - Feather River Cancer Center
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Emeryville, California, United States, 94608
    - Epic Care Partners in Cancer Care
  - Fontana, California, United States, 92335
    - Kaiser Permanente-Fontana
  - Fremont, California, United States, 94538
    - Valley Medical Oncology Consultants-Fremont
  - Harbor City, California, United States, 90710
    - Kaiser Permanente - Harbor City
  - Irvine, California, United States, 92618
    - Kaiser Permanente-Irvine
  - Long Beach, California, United States, 90806
    - Long Beach Memorial Medical Center-Todd Cancer Institute
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90034
    - Kaiser Permanente-Cadillac
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Tom K Lee Inc
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Panorama City, California, United States, 91402
    - Kaiser Permanente - Panorama City
  - Pleasanton, California, United States, 94588
    - Valley Care Health System - Pleasanton
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Riverside, California, United States, 92505
    - Kaiser Permanente-Riverside
  - Saint Helena, California, United States, 94574
    - Saint Helena Hospital
  - San Diego, California, United States, 92120
    - Kaiser Permanente-San Diego Zion
  - San Diego, California, United States, 92134
    - Naval Medical Center -San Diego
  - San Diego, California, United States, 92108
    - Kaiser Permanente-San Diego Mission
  - San Marcos, California, United States, 92078
    - Kaiser Permanente-San Marcos
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - Sunnyvale, California, United States, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Vacaville, California, United States, 95687
    - Northbay Cancer Center
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente-Woodland Hills
- Colorado
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - MedStar Georgetown University Hospital
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
  - Washington, District of Columbia, United States, 20060
    - Howard University Hospital
- Florida
  - Boca Raton, Florida, United States, 33486
    - Boca Raton Comprehensive Cancer Center
  - Daytona Beach, Florida, United States, 32117
    - Florida Hospital Memorial Medical Center
  - Fort Lauderdale, Florida, United States, 33316
    - Broward Health Medical Center
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Jupiter, Florida, United States, 33458
    - Jupiter Medical Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
- Georgia
  - Columbus, Georgia, United States, 31904
    - John B Amos Cancer Center
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Health
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, United States, 60608
    - Mount Sinai Hospital Medical Center
  - Chicago, Illinois, United States, 60625
    - Swedish Covenant Hospital
  - Chicago, Illinois, United States, 60611
    - Hematology and Oncology Associates
  - Chicago, Illinois, United States, 60631
    - Presence Resurrection Medical Center
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
  - Chicago, Illinois, United States, 60657
    - Advocate Illinois Masonic Medical Center
  - Chicago, Illinois, United States, 60657
    - Presence Saint Joseph Hospital-Chicago
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Elk Grove Village, Illinois, United States, 60007
    - AMITA Health Alexian Brothers Medical Center
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Evanston, Illinois, United States, 60202
    - Saint Francis Hospital
  - Kankakee, Illinois, United States, 60901
    - Presence Saint Mary's Hospital
  - La Grange, Illinois, United States, 60525
    - AMITA Health Adventist Medical Center
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Naperville, Illinois, United States, 60540
    - Edward Hospital/Cancer Center
  - Naperville, Illinois, United States, 60540
    - AMG Oncology - Naperville
  - River Forest, Illinois, United States, 60305
    - West Suburban Medical Center
  - Rockford, Illinois, United States, 61108
    - OSF Saint Anthony Medical Center
  - Rockford, Illinois, United States, 61104
    - Swedish American Hospital
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates of Illinois - Skokie
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology Inc-Parkview
  - Indianapolis, Indiana, United States, 46260
    - Saint Vincent Hospital and Health Care Center
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Cancer Care Partners LLC
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Des Moines, Iowa, United States, 50307
    - Mercy Capitol
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Iowa City, Iowa, United States, 52246
    - Iowa City VA Healthcare System
  - Mason City, Iowa, United States, 50401
    - Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - Ottumwa Regional Health Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center-Sioux City
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Waterloo, Iowa, United States, 50701
    - Cedar Valley Medical Specialists
- Kansas
  - Anthony, Kansas, United States, 67003
    - Hospital District Sixth of Harper County
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Prairie Village, Kansas, United States, 66208
    - Kansas City NCI Community Oncology Research Program
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Shawnee Mission, Kansas, United States, 66204
    - Shawnee Mission Medical Center-KCCC
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Cancer Center / Stormont Vail Health
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Wichita NCI Community Oncology Research Program
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Louisville, Kentucky, United States, 40215
    - Doctors Carrol, Sheth, Raghavan
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center-Summa
  - Baton Rouge, Louisiana, United States, 70806
    - Baton Rouge General Medical Center
  - Baton Rouge, Louisiana, United States, 70809
    - Hematology/Oncology Clinic LLP
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
  - New Orleans, Louisiana, United States, 70112
    - University Medical Center New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Louisiana State University Health Science Center
  - New Orleans, Louisiana, United States, 70115
    - Ochsner Baptist Medical Center
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Lewiston, Maine, United States, 04240
    - Saint Mary's Regional Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Baltimore, Maryland, United States, 21225
    - MedStar Harbor Hospital
  - Baltimore, Maryland, United States, 21201
    - Veterans Administration Medical Center-Baltimore
  - Bel Air, Maryland, United States, 21014
    - UM Upper Chesapeake Medical Center
  - Bethesda, Maryland, United States, 20889-5600
    - Walter Reed National Military Medical Center
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
- Massachusetts
  - Attleboro, Massachusetts, United States, 02703
    - Sturdy Memorial Hospital
  - Beverly, Massachusetts, United States, 01915
    - Beverly Hospital
  - Gloucester, Massachusetts, United States, 01930
    - Addison Gilbert Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Escanaba, Michigan, United States, 49829
    - Green Bay Oncology - Escanaba
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Marquette, Michigan, United States, 49855
    - UP Health System Marquette
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Southfield, Michigan, United States, 48075
    - Ascension Providence Hospitals - Southfield
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - Saint Luke's Hospital of Duluth
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Mankato, Minnesota, United States, 56001
    - Mayo Clinic Health Systems-Mankato
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55417
    - Minneapolis VA Medical Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Gulfport, Mississippi, United States, 39502
    - Gulfport Memorial Hospital
  - Hattiesburg, Mississippi, United States, 39404
    - Forrest General Hospital / Cancer Center
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Cape Girardeau, Missouri, United States, 63701
    - Southeast Missouri Hospital
  - Chesterfield, Missouri, United States, 63017
    - Saint Luke's Hospital
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Columbia, Missouri, United States, 65201
    - Veterans Administration
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Kansas City, Missouri, United States, 64114
    - Saint Joseph Health Center
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology Inc
  - Saint Joseph, Missouri, United States, 64507
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint Louis-Cape Girardeau CCOP
  - Saint Louis, Missouri, United States, 63141
    - Center for Cancer Care and Research
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care PC
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Montana Cancer Consortium NCORP
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59102
    - Saint Vincent Frontier Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Great Falls, Montana, United States, 59405
    - Berdeaux, Donald MD (UIA Investigator)
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - North Platte, Nebraska, United States, 69101
    - Great Plains Health Callahan Cancer Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Exeter, New Hampshire, United States, 03833
    - Exeter Hospital
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology Hematology PA-Hooksett
  - Laconia, New Hampshire, United States, 03246
    - LRGHealthcare-Lakes Region General Hospital
  - Manchester, New Hampshire, United States, 03102
    - Norris Cotton Cancer Center-Manchester
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Adminstration New Jersey Health Care System
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Vineland, New Jersey, United States, 08360
    - Inspira Medical Center Vineland
- New York
  - Cooperstown, New York, United States, 13326
    - Mary Imogene Bassett Hospital
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Elmira, New York, United States, 14905
    - Arnot Ogden Medical Center/Falck Cancer Center
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - New York, New York, United States, 10065
    - NYP/Weill Cornell Medical Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Highland Hospital
  - Rochester, New York, United States, 14623
    - Interlakes Foundation Inc-Rochester
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - Syracuse, New York, United States, 13210
    - Syracuse Veterans Administration Medical Center
- North Carolina
  - Burlington, North Carolina, United States, 27215
    - Cone Health Cancer Center at Alamance Regional
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Durham, North Carolina, United States, 27705
    - Durham VA Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Greenville, North Carolina, United States, 27834
    - East Carolina University
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Kinston, North Carolina, United States, 28501
    - Vidant Oncology-Kinston
  - Lumberton, North Carolina, United States, 28358
    - Southeastern Regional Medical Center
  - Oxford, North Carolina, United States, 27565
    - Granville Medical Center
  - Raleigh, North Carolina, United States, 27609
    - Duke Raleigh Hospital
  - Rocky Mount, North Carolina, United States, 27804
    - Nash General Hospital
  - Roxboro, North Carolina, United States, 27573
    - Person Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic
  - Bismarck, North Dakota, United States, 58501
    - Saint Alexius Medical Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Canton, Ohio, United States, 44708
    - Mercy Medical Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Clyde, Ohio, United States, 43410
    - North Coast Cancer Care-Clyde
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Maumee, Ohio, United States, 43537
    - Saint Luke's Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Steubenville, Ohio, United States, 43952
    - Trinity's Tony Teramana Cancer Center
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Norman, Oklahoma, United States, 73071
    - Cancer Care Associates-Norman
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Physicians of Oklahoma-Lakeside
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Salem, Oregon, United States, 97301
    - Salem Hospital
  - The Dalles, Oregon, United States, 97058
    - Mid-Columbia Medical Center/Celilo Cancer Center
- Pennsylvania
  - Butler, Pennsylvania, United States, 16001
    - Butler Memorial Hospital
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Easton, Pennsylvania, United States, 18042
    - Easton Hospital
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Scranton, Pennsylvania, United States, 18510
    - Scranton Hematology Oncology
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - West Chester, Pennsylvania, United States, 19380
    - Chester County Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
- Rhode Island
  - Pawtucket, Rhode Island, United States, 02860
    - Memorial Hospital of Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
  - Providence, Rhode Island, United States, 02906
    - Miriam Hospital
- South Carolina
  - Beaufort, South Carolina, United States, 29902
    - Beaufort Memorial Hospital
  - Charleston, South Carolina, United States, 29401
    - Roper Hospital
  - Easley, South Carolina, United States, 29640
    - Greenville Health System Cancer Institute-Easley
  - Florence, South Carolina, United States, 29506
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29601
    - Greenville Health System Cancer Institute-Andrews
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Faris
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute-Eastside
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Healthcare
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
  - Myrtle Beach, South Carolina, United States, 29572
    - Coastal Cancer Center-Myrtle Beach
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System Cancer Institute-Seneca
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System Cancer Institute-Spartanburg
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center
- Tennessee
  - Nashville, Tennessee, United States, 37208
    - Meharry Medical College
  - Nashville, Tennessee, United States, 37203
    - Nashville Oncology Associates PC
- Texas
  - Dallas, Texas, United States, 75216
    - Dallas VA Medical Center
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Houston, Texas, United States, 77030
    - Michael E DeBakey VA Medical Center
  - Houston, Texas, United States, 77030
    - The Methodist Hospital System
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Houston, Texas, United States, 77030
    - Baylor Saint Luke's Medical Center
  - Temple, Texas, United States, 76508
    - Scott and White Memorial Hospital
- Vermont
  - Bennington, Vermont, United States, 05201
    - Southwestern Vermont Medical Center
  - Berlin, Vermont, United States, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, United States, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Lynchburg, Virginia, United States, 24501
    - Centra Lynchburg Hematology-Oncology Clinic Inc
  - Martinsville, Virginia, United States, 24115
    - Sovah Health Martinsville
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes McGuire Veterans Administration Medical Center
  - South Hill, Virginia, United States, 23970
    - VCU Community Memorial Health Center
- Washington
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Yakima, Washington, United States, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center
  - Huntington, West Virginia, United States, 25702
    - Saint Mary's Medical Center
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, United States, 26101
    - Camden Clark Medical Center
  - Wheeling, West Virginia, United States, 26003
    - Wheeling Hospital/Schiffler Cancer Center
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Fond Du Lac, Wisconsin, United States, 54935
    - Saint Agnes Hospital/Agnesian Cancer Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Janesville, Wisconsin, United States, 53547
    - Mercy Health System
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - La Crosse, Wisconsin, United States, 54601
    - Mayo Clinic Health System-Franciscan Healthcare
  - Madison, Wisconsin, United States, 53717
    - Dean Hematology and Oncology Clinic
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center
  - Mequon, Wisconsin, United States, 53097
    - Columbia Saint Mary's Hospital - Ozaukee
  - Milwaukee, Wisconsin, United States, 53211
    - Columbia Saint Mary's Water Tower Medical Commons
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Racine, Wisconsin, United States, 53405
    - Wheaton Franciscan Cancer Care - All Saints
  - Rhinelander, Wisconsin, United States, 54501
    - Ascension Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - HSHS Saint Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Ascension Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Waukesha, Wisconsin, United States, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Aspirus UW Cancer Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologic or cytologic documentation of primary non-small cell lung cancer
Stage IIIB or IV disease patients who are not candidates for combined modality therapy (chemoradiotherapy)
No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis; patients with central nervous system (CNS) metastases must be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or >= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration
No cavitary lesions
Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the regimen must include four cycles of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not be given beyond the fourth cycle of chemotherapy); patients must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression; patients will be registered 3-5 weeks following day 1 of cycle 4 of prior therapy
No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality therapy for stage III NSCLC
No other primary therapy (including experimental therapy) for NSCLC; palliative radiation therapy must have been completed at least one week before planned start of protocol therapy
Patients must have measurable or non-measurable disease
- Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
- Non-measurable disease: all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
  - Bone lesions
  - Leptomeningeal disease
  - Ascites
  - Pleural/pericardial effusion
  - Lymphangitis cutis/pulmonis
  - Abdominal masses that are not confirmed and followed by imaging techniques
  - Cystic lesions
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Non-pregnant and non-nursing
No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc) interval >= 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:
- Patients with a history of class II heart failure who are asymptomatic on treatment
- Patients with prior anthracycline exposure
- Patients who have received central thoracic radiation that included the heart in the radiotherapy port
Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible
No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year
Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible
Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis
No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome
No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of blood per 24-hour period in the best estimate of the investigator
Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture
The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days before beginning and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus [HIV] protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John?s Wort, efavirenz, tipranavir; other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged
Patients unable to take oral medication are not eligible
Granulocytes >= 1,500/mcl
Platelet count >= 100,000/mcl
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=< 2.5 x ULN; patients with liver metastases may have AST and ALT =< 5 x ULN; all other patients will have AST and ALT =< 2.5 x ULN
Creatinine =< 1.5 mg/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (sunitinib malate) Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Sunitinib Malate Given PO Other Names: Sutent SU011248 SU11248 sunitinib
Placebo Comparator: Arm II (placebo) Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Placebo Given PO Other Names: placebo therapy PLCB sham therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)	Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.	Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Time from randomization to death (up to 5 years)	Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.	Time from randomization to death (up to 5 years)
Response Rate (RR) Time Frame: Duration of treatment (up to 5 years)	The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.	Duration of treatment (up to 5 years)
Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale Time Frame: At 3 months	The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.	At 3 months
Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale Time Frame: At 3 months	The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.	At 3 months
Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Time Frame: Duration of study (up to 5 years)	Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.	Duration of study (up to 5 years)

Other Outcome Measures

Outcome Measure	Time Frame
VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS Time Frame: Up to 6 weeks	Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Mark A Socinski, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Baggstrom MQ, Socinski MA, Wang XF, Gu L, Stinchcombe TE, Edelman MJ, Baker S Jr, Feliciano J, Novotny P, Hahn O, Crawford JA, Vokes EE. Maintenance Sunitinib following Initial Platinum-Based Combination Chemotherapy in Advanced-Stage IIIB/IV Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase III Study-CALGB 30607 (Alliance). J Thorac Oncol. 2017 May;12(5):843-849. doi: 10.1016/j.jtho.2017.01.022. Epub 2017 Feb 1.

Helpful Links

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2008

Primary Completion (Actual)

November 8, 2013

Study Completion (Actual)

May 28, 2015

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 9, 2008

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

NCI-2009-00469 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180821 (U.S. NIH Grant/Contract)
U10CA031946 (U.S. NIH Grant/Contract)
CDR0000597649
CALGB 30607 (Other Identifier: Alliance for Clinical Trials in Oncology)
CALGB-30607 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors

Metastatic Lung Non-Small Cell Carcinoma | Pancreatic Ductal Adenocarcinoma | Advanced Malignant Solid Neoplasm | Unresectable Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Stage III Pancreatic Cancer AJCC v6 and v7 | Stage IV Pancreatic Cancer AJCC v6 and v7 | Stage IIIA Lung Non-Small... and other conditions

United States, Canada
M.D. Anderson Cancer Center

Active, not recruiting

Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer

Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...

United States
Radiation Therapy Oncology Group
National Cancer Institute (NCI); NRG Oncology

Active, not recruiting

Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

Stage II Non-Small Cell Lung Cancer AJCC v7 | Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7

United States
Roswell Park Cancer Institute

Active, not recruiting

Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

Stage IB Non-Small Cell Lung Carcinoma AJCC v7 | Stage II Non-Small Cell Lung Cancer AJCC v7 | Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage I Non-Small Cell Lung Cancer AJCC v7 | Stage...

United States
Roswell Park Cancer Institute
National Cancer Institute (NCI)

Terminated

Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy

Lung Non-Squamous Non-Small Cell Carcinoma | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV... and other conditions

United States
National Cancer Institute (NCI)

Active, not recruiting

Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...

United States
Emory University
National Cancer Institute (NCI); National Institutes of Health (NIH); RefleXion...

Completed

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

Stage IB Non-Small Cell Lung Carcinoma AJCC v7 | Stage II Non-Small Cell Lung Cancer AJCC v7 | Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Stage I Lung Cancer | Stage II Lung Cancer | Stage I Non-Small Cell Lung Cancer AJCC v7 | Stage IA Non-Small...

United States

Clinical Trials on Laboratory Biomarker Analysis

Children's Oncology Group
National Cancer Institute (NCI)

Completed

Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

Leukemia
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Active, not recruiting

Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

Leukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic Leukemia

United States
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Untreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic Leukemia

United States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
Children's Oncology Group
National Cancer Institute (NCI)

Completed

DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia

Childhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic Leukemia

United States
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Completed

Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

Lung Cancer

United States
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Completed

Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202

Lung Cancer

United States
Children's Oncology Group
National Cancer Institute (NCI)

Withdrawn

Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

Clear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney Neoplasm

United States
Gynecologic Oncology Group
National Cancer Institute (NCI)

Withdrawn

Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers

Breast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation Carrier

United States
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Biomarkers in Samples From Younger Patients With Wilms Tumor

Wilms Tumor and Other Childhood Kidney Tumors

United States
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

Childhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

United States

Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

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Clinical Trials on Stage IV Non-Small Cell Lung Cancer AJCC v7

Clinical Trials on Laboratory Biomarker Analysis

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