A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Disease Free Survival (DFS)
DFS is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.
Every 3 months during active phase and every 6 months during long term follow-up (up to 6 years)
No
Medical Monitor
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
OSI-774-302
NCT00373425
September 2006
June 2016
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Mountain States Tumor Institute | Boise, Idaho 83712 |
| University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Missouri Cancer Associates | Columbia, Missouri 65201 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| Hematology Oncology, P.C. | Stamford, Connecticut 06902 |
| St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
| Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs, California 92262 |
| Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Cancer Care Northwest | Spokane, Washington 99202 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| Caritas St. Elizabeth's Medical Center | Brighton, Massachusetts 02135-2997 |
| Tower Cancer Research Foundation | Beverly Hills, California 90211 |
| West Clinic | Memphis, Tennessee 38117 |
| Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
| St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| Cancer Centers of Florida | Orlando, Florida 32806 |
| Norton Healthcare, Inc. | Louisville, Kentucky 40202 |
| Hoag Cancer Center | Newport Beach, California 92658 |
| Texas Oncology | Dallas, Texas |
| University of New Mexico | Albuquerque, New Mexico 87131 |
| North Texas Regional Cancer Center | Plano, Texas 75075 |
| University of Arkansas for Medical Science | Little Rock, Arkansas 72205 |
| Rocky Mountain Cancer Center-Midtown | Denver, Colorado 80218 |
| Northwest Cancer Specialists-Vancouver | Vancouver, Washington 98684 |
| Bay Area Cancer Research Group, LLC | Concord, California 94520 |
| Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
| Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
| Hematology Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
| Cancer Care of Maine | Bangor, Maine 04401 |
| Lake Vista Cancer Center | Lewisville, Texas 75067 |
| Onc and Hem Associates of SW VA, Inc. | Salem, Virginia 24153 |
| Cancer Care Northwest-North | Spokane, Washington 99218 |
| University of Kansas Hospital | Kansas City, Kansas 66160 |
| The Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
| Minnesota Oncology Hematology | Minneapolis, Minnesota 55404 |
| Paris Regional Cancer Center | Paris, Texas 75460 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| South Carolina Oncology Assoc., PA | Columbia, South Carolina 29201 |
| Cancer Care Centers of South Texas - HOAST | San Antonio, Texas 78229 |
| Cookeville Regional Medical Center | Cookeville, Tennessee 38501 |
| Central Georgia Cancer Care, PC | Macon, Georgia 31201 |
| Kootenai Cancer Center | Post Falls, Idaho 83854 |
| NH Oncology-Hematology PA | Hooksett, New Hampshire 03106 |
| Interlakes Oncology Hematology, PC | Rochester, New York 14623 |
| Connecticut Oncology & Hematology, LLP | Torrington, Connecticut 06790 |
| Advanced Medical Specialties | Miami, Florida 33176 |
| Northwest Georgia Oncology Centers, PC | Marietta, Georgia 30060 |
| Watson Clinic LLP | Lakeland, Florida 33805 |
| Mecklenburg Medical Group | Charlotte, North Carolina |
| Cedars-Sinai Outpatient Cancer Center | Los Angeles, California |
| City of Hope Nat`l Medical Center | Duarte, California 91010 |
| USC/ Norris Comprehensive Cancer Center | Los Angeles, California 90033 |
| USC/ Norris Comprehensive Cncer Center | Los Angeles, California 90033 |
| University of California, San Francisco Comprehensive Cancer Center | San Francisco, California 94143-1770 |
| City of Hope Medical Group (COHMG) | South Pasadena, California 91030 |
| Rocky Mountain Cancer Center- Aurora | Aurora, Colorado 80012 |
| Rocky Mountain Cancer Centers-Boulder | Boulder, Colorado 80303 |
| Rocky Mountain Cancer Centers- Rose | Denver, Colorado 80220 |
| Rocky Mountain Cancer Centers-Littleton | Littleton, Colorado 80120-4413 |
| Rocky Mountain Cancer Center-Sky Ridge | Lone Tree, Colorado 80124 |
| Rocky Mountain Cancer Centers-Longmont | Longmont, Colorado 80501 |
| Rocky Mountain Cancer Center-Parker | Parker, Colorado 80138 |
| Rocky Mountain Cancer Centers-Pueblo | Pueblo, Colorado 81008 |
| Florida Cancer Institute-New Hope | Hudson, Florida 34667 |
| Integrated Community Oncology Network, Division of Clinical Research | Jacksonville, Florida 32216 |
| Florida Cancer Institute- New Hope | New Port Richey, Florida 34655 |
| Cancer Centers of Florida, PPA | Ocoee, Florida 34761 |
| Peachtree Hematology-Oncology Consultants, P.C. | Atlanta, Georgia 30309 |
| University of Chicago, Section of Hematology/Oncology MC2115 | Chicago, Illinois 60637 |
| Joliet Oncology Hematology Assoc., LTD | Joliet, Illinois 60435 |
| Leonard J. Chabert Medical Center; Pulmonary | Houma, Louisiana 70363 |
| St. Joseph Medical Center`s Cancer Institute | Towson, Maryland 21204 |
| St. Francis Medical Center | Grand Island, Nebraska 68803 |
| NH Oncology-Hematology PA (Co) | Concord, New Hampshire 03301 |
| New Mexico Cancer Care, Cancer Institute of New Mexico | Santa Fe, New Mexico 87505 |
| St. Vincent Regional Cancer Care Center | Santa Fe, New Mexico 87505 |
| The New York Presbyterian-Weill Medical College of Cornell University | New York, New York 10065 |
| State University of New York at Stony Brook | Stony Brook, New York 11794 |
| Aultman Hospital/ North Canton Medical Foundation | Canton, Ohio 44710 |
| University Hopsitals of Cleveland | Cleveland, Ohio 44106 |
| Hematology Oncology Consultants Inc. | Columbus, Ohio 43228 |
| Earle A Chiles Research Institute | Portland, Oregon 97213 |
| Northwest Cancer Specialists, PC | Portland, Oregon 97225 |
| Cancer Care Associates - Mediacl Oncology | Bethlehem, Pennsylvania 18015 |
| Allegheny General Hospital - Allegheny Singer Research Institute | Pittsburg, Pennsylvania 15212 |
| Cancer Centers of the Carolinas, Seneca | Seneca, South Carolina 29672 |
| Family Cancer Center, PLLC | Collierville, Tennessee 38017 |
| Texas Oncology, P.A. - Amarillo | Amarillo, Texas 79106 |
| Texas Oncology Beaumont | Beaumont, Texas 77702-1449 |
| Texas Oncology Texas Cancer Center at Medical City | Dallas, Texas 75230-2510 |
| Southwest Forth Worth Cancer Center | Fort Worth, Texas 76132 |
| Texas Oncology, Fort Worth | Ft. Worth, Texas 76104 |
| Cancer Care Centers of South Texas-HOAST | San Antonio, Texas 78229 |
| Texas Oncology -Tyler | Tyler, Texas 75702 |
| Texas Oncology Cancer Care and Researh Center | Waco, Texas 76712 |
| Onc and Hem Assoc of SW VA, Inc | Salem, Virginia 24153 |
| Univ. of Washington/ Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Cancer Care Northwest-Valley | Spokane Valley, Washington 99216 |
| Northwest Cancer Specialist, P.C. | Vancouver, Washington 98686 |