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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

Phase 3
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Primary tissue from patient's surgery must be Epidermal growth factor receptor
(EGFR)-positive by certain tests

- Patients may have up to 4 cycles of chemotherapy after surgery

- Complete removal of the tumor by surgery

- Able to start drug under the following timelines:

- 6 months from the day of surgery for patients who get chemotherapy

- 3 months from the day of surgery for those who do not get chemotherapy

- Confirmed diagnosis of Stage IB-IIIA NSCLC

- Patients must be accessible for follow-up visits

Exclusion Criteria:

- History of prior radiotherapy for NSCLC either before or after surgery

- History of heart disease or uncontrolled heart arrhythmias within the previous year

- History of poorly controlled Gastrointestinal (GI) disorders that could affect the
absorption of study drug

- History of other cancer except certain skin or cervical cancers, Patients who have
had other cancer are eligible if they have remained disease free for at least 5 years

- Patients who have received chemotherapy for NSCLC before surgery

- Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with
carcinoid tumors are not eligible

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival (DFS)

Outcome Description:

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.

Outcome Time Frame:

Every 3 months during active phase and every 6 months during long term follow-up (up to 6 years)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

June 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Adjuvant Non-small Cell Lung Cancer
  • Tarceva
  • Early-stage Lung Cancer
  • Adjuvant
  • EGFR-positive tumor
  • Stage IB Non-small Cell Lung Cancer
  • Stage II Non-small Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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