Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

June 20, 2023 updated by: ECOG-ACRIN Cancer Research Group

Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.

Study Overview

Detailed Description

OBJECTIVES:

Primary

  • To compare the overall survival (OS) of patients with advanced non-squamous non-small cell lung cancer (NSCLC) treated with maintenance therapy with bevacizumab vs pemetrexed disodium vs bevacizumab and pemetrexed disodium following induction therapy.

Secondary

  • To determine the response rate in patients treated with these regimens.
  • To evaluate the progression-free survival (PFS) of patients treated with these regimens.
  • To define the toxicity of these regimens in these patients.
  • To determine the frequency of polymorphisms in VEGF 3578 AA, 1154 AA, ABCB1 G2677TT/AA, and ERCC-118 TT in patients treated with induction therapy comprising paclitaxel, carboplatin and bevacizumab and determine the association between genotypes and response rate.
  • To determine the association between bevacizumab and pemetrexed disodium population pharmacokinetics and patient-specific covariate with bevacizumab or pemetrexed disodium toxicity.
  • To determine the frequency of TSER*3 polymorphisms in NSCLC and the association between TSER polymorphisms and benefit from pemetrexed disodium.
  • To evaluate TS and ERCC1 expression by RT-PCR and MTAP mutations in existing tumor specimens as a predictor of pemetrexed disodium response.
  • To evaluate polymorphisms within CYPs 2C8, 3A4, 3A5 and/or the UGT1A1 collectively or monogenically as markers for variation in efficacious and/or toxic response of individuals to treatment with taxanes.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender (male vs female), stage of disease (IIIB-T4Nx [with nodule in ipsilateral lung lobe and not candidate for combined chemotherapy and radiation] and IV M1a vs IV M1b vs recurrent), best response to first-time therapy (complete response/partial response vs stable disease), and smoking status (never vs smoker).

  • Induction therapy (Arm I): Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance Therapy: Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Treatment begins within 6 weeks of the last day of induction chemotherapy administration.

    • Arm A: Patients receive bevacizumab IV over 30-90 minutes on day 1.
    • Arm B: Patients receive pemetrexed disodium IV over 10 minutes on day 1.
    • Arm C: Patients receive bevacizumab as in arm A and pemetrexed as in arm B. In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Some patients undergo blood sample collection at baseline and periodically during study for correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 2-5 years.

Study Type

Interventional

Enrollment (Actual)

1516

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

    • Alabama
      • Anniston, Alabama, United States, 36207
        • Regional Medical Center
    • Alaska
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
    • California
      • Fairfield, California, United States, 94533
        • North Bay Cancer Center
      • Long Beach, California, United States, 90806
        • Todd Cancer Institute at Long Beach Memorial Medical Center
      • Monterey, California, United States, 93940
        • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Medical Center - Palo Alto
      • Paradise, California, United States, 95969
        • Feather River Hospital Cancer Center
      • Roseville, California, United States, 95661
        • Sutter Cancer Center at Roseville Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Cancer Center
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Hospital
      • Stanford, California, United States, 94305-5824
        • Stanford Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80204
        • St. Anthony Central Hospital
      • Denver, Colorado, United States, 80218
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80222
        • CCOP - Colorado Cancer Research Program
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente - Denver
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente - Lafayette
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Hope Cancer Care Center at Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Praxair Cancer Center at Danbury Hospital
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
      • Hartford, Connecticut, United States, 06102-5037
        • Helen and Harry Gray Cancer Center at Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
      • Washington, District of Columbia, United States, 20002
        • Kaiser Permanente at Capitol Hill Medical Center
    • Florida
      • Deerfield Beach, Florida, United States, 33064-3596
        • North Broward Medical Center
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center Cancer Center
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jupiter, Florida, United States, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Pensacola, Florida, United States, 32514
        • Sacred Heart Medical Oncology
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida - Weston
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Cancer Center at Phoebe Putney Memorial Hospital
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
      • Savannah, Georgia, United States, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
      • Valdosta, Georgia, United States, 31602
        • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Lewiston, Idaho, United States, 83501
        • St. Joseph Regional Medical Center
      • Meridian, Idaho, United States, 83642
        • Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Mountain States Tumor Institute
      • Twin Falls, Idaho, United States, 83301
        • Mountain States Tumor Institute at St. Luke's
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Cancer Care Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, United States, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, United States, 60657
        • Saint Joseph Hospital
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Chicago, Illinois, United States, 60631
        • Resurrection Medical Center
      • Elmhurst, Illinois, United States, 60126
        • Elmhurst Memorial Hospital
      • Evanston, Illinois, United States, 60202
        • St. Francis Hospital
      • Freeport, Illinois, United States, 61032
        • Leonard C. Ferguson Cancer Center
      • Geneva, Illinois, United States, 60134
        • Delnor Hospital - Geneva
      • Highland Park, Illinois, United States, 60035
        • Kellogg Cancer Care Center
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Kankakee, Illinois, United States, 60901
        • Provena St. Mary's Regional Cancer Center - Kankakee
      • La Grange, Illinois, United States, 60525
        • La Grange Memorial Hospital
      • Libertyville, Illinois, United States, 60048
        • North Shore Oncology and Hematology Associates, Limited - Libertyville
      • Niles, Illinois, United States, 60714
        • Cancer Care and Hematology Specialists of Chicagoland - Niles
      • River Forest, Illinois, United States, 60305
        • West Suburban Center for Cancer Care
      • Rockford, Illinois, United States, 61104-2315
        • Swedish-American Regional Cancer Center
      • Rockford, Illinois, United States, 61108
        • Center for Cancer Care at OSF Saint Anthony Medical Center
      • Skokie, Illinois, United States, 60076
        • Hematology Oncology Associates - Skokie
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Central Dupage Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Lafayette, Indiana, United States, 47904
        • Clarian Arnett Cancer Care
      • Merrillville, Indiana, United States, 46410
        • Suniti Medical Corporation
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • Richmond, Indiana, United States, 47374
        • Reid Hospital & Health Care Services
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, PC
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Cedar Rapids, Iowa, United States, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52402
        • Iowa Blood and Cancer Care
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center - West Lakes
      • Council Bluffs, Iowa, United States, 51503
        • Heartland Oncology and Hematology
      • Des Moines, Iowa, United States, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, United States, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Waterloo, Iowa, United States, 50702
        • Covenant Cancer Treatment Center
      • West Des Moines, Iowa, United States, 50266-7700
        • Methodist West Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Providence Medical Center
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's Hospital - South
      • Prairie Village, Kansas, United States, 66208
        • CCOP - Kansas City
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Mitchell Memorial Cancer Center at Owensboro Medical Health System
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center - Baton Rouge
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Health Center - Bluebonnet
      • Covington, Louisiana, United States, 70433
        • Ochsner Health Center - Covington
      • Monroe, Louisiana, United States, 71210
        • Louisiana State University Health Sciences Center - Monroe
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70115
        • New Orleans Cancer Institute at Memorial Medical Center
      • New Orleans, Louisiana, United States, 70112
        • Medical Center of Louisiana - New Orleans
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, United States, 21244
        • Kaiser Permanente at Woodlawn Medical Center
      • Cumberland, Maryland, United States, 21502
        • Regional Cancer Center at Western Maryland Health System - Sacred Heart Campus
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital Regional Cancer Therapy Center
      • Gaithersburg, Maryland, United States, 20879
        • Kaiser Permanente - Gaithersburg Medical Center
      • Largo, Maryland, United States, 20774
        • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
      • Salisbury, Maryland, United States, 21801
        • Peninsula Regional Medical Center
      • Silver Spring, Maryland, United States, 20910
        • Holy Cross Hospital
    • Massachusetts
      • Attleboro, Massachusetts, United States, 02703
        • Sturdy Memorial Hospital
      • Gloucester, Massachusetts, United States, 01930
        • Addison Gilbert Hospital
      • Plymouth, Massachusetts, United States, 02360
        • Jordan Hospital Club Cancer Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Marquette, Michigan, United States, 49855
        • Upper Michigan Cancer Center at Marquette General Hospital
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital - Monroe
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Bemidji
      • Brainerd, Minnesota, United States, 56401
        • St. Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, United States, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, United States, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Mankato, Minnesota, United States, 56002
        • Immanuel St. Joseph's
      • Maplewood, Minnesota, United States, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology - Maplewood
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center - Minneapolis
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Humphrey Cancer Center at North Memorial Outpatient Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital Cancer Care Center
      • Shakopee, Minnesota, United States, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology - Woodbury
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center at Carrie J. Babb Cancer Center
      • Branson, Missouri, United States, 65616
        • Skaggs Cancer Center at Skaggs Regional Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Jefferson City, Missouri, United States, 65109
        • Goldschmidt Cancer Center
      • Joplin, Missouri, United States, 64804
        • St. John's Regional Medical Center
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology Oncology Associates, Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Parvin Radiation Oncology
      • Rolla, Missouri, United States, 65401
        • Phelps County Regional Medical Center
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic Cancer and Hematology - Rolla
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology, Incorporated
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, United States, 63128
        • St. Anthony's Cancer Center
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, United States, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Helena, Montana, United States, 59601
        • St. Peter's 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 at KRMC
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Kearney, Nebraska, United States, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • Lincoln, Nebraska, United States, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, United States, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68131-2197
        • Creighton University Medical Center
      • Omaha, Nebraska, United States, 68130
        • Lakeside Hospital
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Seacoast Cancer Center at Wentworth - Douglass Hospital
      • Nashua, New Hampshire, United States, 03060
        • Oncology Center at St. Joseph Hospital
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Morristown, New Jersey, United States, 07960
        • Carol G. Simon Cancer Center at Morristown Memorial Hospital
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Newark, New Jersey, United States, 07103
        • UMDNJ University Hospital
      • Sparta, New Jersey, United States, 07871
        • Frederick R. and Betty M. Smith Cancer Treatment Center
      • Summit, New Jersey, United States, 07901
        • Overlook Hospital
      • Vineland, New Jersey, United States, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
      • Voorhees, New Jersey, United States, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, United States, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
      • Glens Falls, New York, United States, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • Staten Island, New York, United States, 10305
        • Nalitt Cancer Institute at Staten Island University Hospital
      • Stony Brook, New York, United States, 11794-9446
        • Stony Brook University Cancer Center
      • Utica, New York, United States, 13502
        • Faxton Regional Cancer Center
      • White Plains, New York, United States, 10601
        • Dickstein Cancer Treatment Center at White Plains Hospital Center
    • North Carolina
      • Asheboro, North Carolina, United States, 27203-5400
        • Randolph Hospital
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Greensboro, North Carolina, United States, 27403-1198
        • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Cancer Center
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Statesville, North Carolina, United States, 28677
        • Iredell Memorial Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58102
        • MeritCare Broadway
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center at MeritCare Hospital
      • Fargo, North Dakota, United States, 58103
        • Dakota Cancer Institute at Dakota Clinic - South University
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center at Altru Hospital
      • Minot, North Dakota, United States, 58701
        • Trinity Cancercare Center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Cleveland Clinic Beachwood Family Health and Surgery Center
      • Bowling Green, Ohio, United States, 43402
        • Wood County Oncology Center
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
      • Canton, Ohio, United States, 44708
        • Mercy Cancer Center at Mercy Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Cancer Care Center at MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, United States, 45420
        • CCOP - Dayton
      • Elyria, Ohio, United States, 44035
        • Community Cancer Center
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, United States, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Independence, Ohio, United States, 44131
        • Cleveland Clinic Cancer Center
      • Kettering, Ohio, United States, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
      • Maumee, Ohio, United States, 43537-1839
        • Northwest Ohio Oncology Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest General Health Center
      • Orange Village, Ohio, United States, 44122
        • UHHS Chagrin Highlands Medical Center
      • Oregon, Ohio, United States, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic - Oregon
      • Parma, Ohio, United States, 44129
        • Parma Community General Hospital
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Incorporated
      • Strongsville, Ohio, United States, 44136
        • Cleveland Clinic Foundation - Strongsville
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, United States, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, United States, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, United States, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Westlake, Ohio, United States, 44145
        • UHHS Westlake Medical Center
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic - Wooster
      • Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
        • United States Air Force Medical Center - Wright-Patterson
      • Xenia, Ohio, United States, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Cancer Care Associates - Norman
      • Oklahoma City, Oklahoma, United States, 73120
        • Cancer Care Associates - Mercy Campus
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Darby, Pennsylvania, United States, 19023
        • Mercy Fitzgerald Hospital
      • Ephrata, Pennsylvania, United States, 17522
        • Ephrata Cancer Center at Ephrata Community Hospital
      • Erie, Pennsylvania, United States, 16505
        • Regional Cancer Center - Erie
      • Furlong, Pennsylvania, United States, 18925
        • Fox Chase Cancer Center Buckingham
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, United States, 17331
        • Cherry Tree Cancer Center
      • Harrisburg, Pennsylvania, United States, 17110-2098
        • PinnacleHealth Regional Cancer Center at Polyclinic Hospital
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Hazleton Cancer Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Media, Pennsylvania, United States, 19063
        • Riddle Memorial Hospital Cancer Center
      • Paoli, Pennsylvania, United States, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19114
        • Frankford Hospital Cancer Center - Torresdale Campus
      • Philadelphia, Pennsylvania, United States, 19143
        • Iris V. Henderson Cancer Center at Mercy Hospital of Philadelphia
      • Reading, Pennsylvania, United States, 19605
        • St. Joseph Medical Center
      • Reading, Pennsylvania, United States, 19612-6052
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Cancer Center at Guthrie Clinic Sayre
      • Scranton, Pennsylvania, United States, 18501
        • Mercy Hospital Cancer Center - Scranton
      • Scranton, Pennsylvania, United States, 18510
        • Hematology and Oncology Associates of Northeastern Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Grand View Hospital
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group - Scenery Park
      • West Chester, Pennsylvania, United States, 19380
        • Chester County Hospital
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Williamsport, Pennsylvania, United States, 17701
        • Susquehanna Cancer Center at Divine Providence Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - Main Line Health
      • York, Pennsylvania, United States, 17405
        • York Cancer Center at Apple Hill Medical Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Easley, South Carolina, United States, 29640
        • Cancer Centers of the Carolinas - Easley
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital Cancer Center
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas - Faris Road
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas - Grove Commons
      • Greenville, South Carolina, United States, 29601
        • Bon Secours St. Francis Health System
      • Greer, South Carolina, United States, 29650
        • Cancer Centers of the Carolinas - Greer Medical Oncology
      • Seneca, South Carolina, United States, 29672
        • Cancer Centers of the Carolinas - Seneca
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Cancer Centers of the Carolinas - Spartanburg
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Oncology Services of Aberdeen
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • West Tennessee Cancer Center at Jackson-Madison County General Hospital
      • Kingsport, Tennessee, United States, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Abilene, Texas, United States, 79601
        • Hendrick Cancer Center
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Community Cancer Center at Rutland Regional Medical Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology, Incorporated
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates - Hampton
      • McLean, Virginia, United States, 22102
        • Kaiser Permanente Tysons Corner Medical Center
      • Norton, Virginia, United States, 24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
    • Washington
      • Auburn, Washington, United States, 98002
        • Auburn Regional Center for Cancer Care
      • Bellevue, Washington, United States, 98004
        • Overlake Cancer Center at Overlake Hospital Medical Center
      • Centralia, Washington, United States, 98531-9027
        • Providence Centralia Hospital
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, United States, 98003
        • St. Francis Hospital
      • Kirkland, Washington, United States, 98033
        • Cascade Cancer Center at Evergreen Hospital Medical Center
      • Olympia, Washington, United States, 98506-5166
        • Providence St. Peter Hospital Regional Cancer Center
      • Puyallup, Washington, United States, 98372
        • Good Samaritan Cancer Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98104
        • Pacific Medical Center
      • Spokane, Washington, United States, 99204-2967
        • Rockwood Clinic Cancer Treatment Center
      • Tacoma, Washington, United States, 98405-3004
        • Franciscan Cancer Center at St. Joseph Medical Center
      • Tacoma, Washington, United States, 98405
        • Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • CCOP - Northwest
      • Tacoma, Washington, United States, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Tacoma, Washington, United States, 98499
        • St. Clare Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Health Sciences Center - Charleston
      • Morgantown, West Virginia, United States, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Memorial Hospital
      • Green Bay, Wisconsin, United States, 54301
        • Bellin Memorial Hospital
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, United States, 54311
        • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
      • Janesville, Wisconsin, United States, 53547
        • Mercy Regional Cancer Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Manitowoc, Wisconsin, United States, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Vince Lombardi Cancer Clinic - Marinette
      • Milwaukee, Wisconsin, United States, 53210
        • Wheaton Franciscan Cancer Care - St. Joseph
      • Mukwonago, Wisconsin, United States, 53149
        • D.N. Greenwald Center
      • Oconomowoc, Wisconsin, United States, 53066
        • Regional Cancer Center at Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Sheboygan, Wisconsin, United States, 53081
        • St. Nicholas Hospital
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic - Sheboygan
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic - Two Rivers
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital Regional Cancer Center
      • Wausau, Wisconsin, United States, 54401
        • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
      • Wauwatosa, Wisconsin, United States, 53226
        • Oncology Alliance, SC - Milwaukee - West
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Riverview UW Cancer Center at Riverview Hospital
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology

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

No

Description

Inclusion Criteria (Step 1 Induction Therapy):

  • Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)
  • Predominant non-squamous histology (NSCLC not otherwise specified allowed). Mixed tumors are categorized by the predominant cell type.
  • Stage IV disease including M1a or M1b stages or recurrent disease
  • Stage IIIB (T4NX) disease with ipsilateral lung lobe allowed provided patients are not candidates for combined chemotherapy or radiotherapy
  • At least 12 months since prior adjuvant chemotherapy
  • At least 2 weeks since prior radiotherapy
  • Prior carboplatin allowed provided it was given as part of adjuvant chemotherapy
  • Patients with brain metastasis must have received local therapy to the brain and have no evidence of progression in the brain for at least 2 weeks from the time of completion of local therapy, prior to registration
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Leukocytes ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ institutional upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min
  • Urine protein:urine dipstick ≤ 0-1+ (if > 1+, urine protein creatinine ratio must be < 1)
  • Measurable or non-measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumours) criteria
  • Patients with hypertension must be adequately controlled (BP < 150/100 mm Hg) with appropriate anti-hypertensive therapy or diet
  • Concurrent therapeutic anti-coagulation allowed
  • Fertile patients must agree to abstain from sexual intercourse or to use adequate contraceptive methods during and for at least 6 months after completion of study therapy

Exclusion Criteria (Step 1 Induction Therapy):

  • Prior malignancy within the past 3 years except superficial melanoma, basal cell carcinoma, or carcinoma in situ
  • Prior systemic chemotherapy for advanced stage lung cancer
  • Prior use of paclitaxel, pemetrexed disodium, or bevacizumab
  • Major hemoptysis within the past 4 weeks
  • Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
  • History of arterial thrombotic events or major bleeding within the past 12 months
  • Major surgery such as thoracotomy, laparotomy, craniotomy, or significant traumatic injury within 6 weeks prior to registration. Biopsy procedures and chest tube insertion are not considered major surgery for the purpose of this protocol.
  • Core biopsy within 7 days of registration
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within the past 6 months
  • Clinically significant cardiovascular disease
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • History of serious non-healing wounds, ulcers, or bone fractures
  • Cavitary lesions in the lungs
  • Pregnant or nursing
  • Concurrent anti-retroviral therapy in patients with HIV infection

Inclusion Criteria (Step 2 Maintenance Therapy):

  • Patient must have an overall stable or better response after 4 courses of induction therapy
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Patients must be registered to Step 2 within 6 weeks of the last day of chemotherapy administration on Step 1
  • Acceptable bone marrow, renal and hepatic function within 2 weeks of registration

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Induction then Maintenance with Bevacizumab)

Induction Therapy:

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Maintenance Therapy:

Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.

Given IV
Other Names:
  • carboplatin for injection or platinum diamine [1,1-cyclobutane-decarbozxylate (2-0,0')-,(SP-4-2)]
Given IV
Other Names:
  • Taxol
  • NSC 673089
Given IV
Other Names:
  • NSC 704865
  • RhuMAb VEGF
  • Recombinant Humanized Monoclonal Anti-VEGF Antibody
Experimental: Arm B (Induction then Maintenance with Pemetrexed)

Induction Therapy:

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Maintenance Therapy:

Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.

Given IV
Other Names:
  • carboplatin for injection or platinum diamine [1,1-cyclobutane-decarbozxylate (2-0,0')-,(SP-4-2)]
Given IV
Other Names:
  • Taxol
  • NSC 673089
Given IV
Other Names:
  • NSC 704865
  • RhuMAb VEGF
  • Recombinant Humanized Monoclonal Anti-VEGF Antibody
Given IV
Other Names:
  • L-Glutamic acid
  • N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-
  • disodium salt
  • heptahydrate
Experimental: Arm C (Induction then Maintenance with Bevacizumab & Pemetrexed)

Induction Therapy:

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Maintenance Therapy:

Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab as in arm A and pemetrexed as in arm B.

Given IV
Other Names:
  • carboplatin for injection or platinum diamine [1,1-cyclobutane-decarbozxylate (2-0,0')-,(SP-4-2)]
Given IV
Other Names:
  • Taxol
  • NSC 673089
Given IV
Other Names:
  • NSC 704865
  • RhuMAb VEGF
  • Recombinant Humanized Monoclonal Anti-VEGF Antibody
Given IV
Other Names:
  • L-Glutamic acid
  • N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-
  • disodium salt
  • heptahydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Overall survival is defined as the time from randomization to death or date last known alive.

The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.

Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is evaluated based on RECIST criteria and defined as appearance of one or more new lesions, unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on current step. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.

Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5
Response Rate
Time Frame: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Response is evaluated based on RECIST criteria v1.1 and defined as either complete response or partial response. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the current step's baseline sum diameters.

The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.

Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Association Between Genotypes and Response Rate
Time Frame: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5
To determine the frequency of polymorphisms in VEGF 3578 AA, 1154 AA, ABCB1 G2677TT/AA and ERCC-118 TT in patients with NSCLC receiving paclitaxel, carboplatin and bevacizumab therapy and determine the association between genotypes and response rate.
Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5
The Association Between Bevacizumab and Pemetrexed Population Pharmacokinetics and Patient Specific Covariates With Bevacizumab or Pemetrexed Toxicity
Time Frame: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
The Frequency of TSER*3 Polymorphisms in NSCLC and the Association Between TSER Polymorphisms and Benefit From Pemetrexed
Time Frame: Assessed every 3 months for 2 years and every 6 months for years 3-5
Assessed every 3 months for 2 years and every 6 months for years 3-5
The Association Between TS and ERCC1 Expression and Pemetrexed Response
Time Frame: Assessed every 3 months for 2 years and every 6 months for years 3-5
Assessed every 3 months for 2 years and every 6 months for years 3-5
The Associations Between Polymorphisms Within CYPs 2C8, 3A4, 3A5 and/or the UGT1A1 Collectively or Monogenically and Efficacy and/or Toxicities
Time Frame: Assessed every 3 months for 2 years and every 6 months for years 3-5
Assessed every 3 months for 2 years and every 6 months for years 3-5

Collaborators and Investigators

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

Investigators

  • Study Chair: Suresh Ramalingam, MD, Emory University

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.

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)

October 25, 2010

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimated)

April 21, 2010

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Lung Cancer

Clinical Trials on Carboplatin

3
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