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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 CenterTucson, Arizona  85724
Loyola University Medical CenterMaywood, Illinois  60153
Loma Linda University Medical CenterLoma Linda, California  92354
Rush University Medical CenterChicago, Illinois  60612-3824
Texas Oncology, P.A.Dallas, Texas  75246
Hackensack University Medical CenterHackensack, New Jersey  07601
Mountain States Tumor InstituteBoise, Idaho  83712
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Virginia Oncology AssociatesNewport News, Virginia  23606
Montefiore Medical CenterBronx, New York  10467-2490
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Rocky Mountain Cancer CenterDenver, Colorado  80218
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Rocky Mountain Cancer CentersThornton, Colorado  80260
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Hematology Oncology, P.C.Stamford, Connecticut  06902
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Comprehensive Cancer Center at Desert Regional Medical CenterPalm Springs, California  92262
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Cancer Care NorthwestSpokane, Washington  99202
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Tower Cancer Research FoundationBeverly Hills, California  90211
West ClinicMemphis, Tennessee  38117
Nebraska Methodist HospitalOmaha, Nebraska  68114
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Cancer Centers of FloridaOrlando, Florida  32806
Norton Healthcare, Inc.Louisville, Kentucky  40202
Hoag Cancer CenterNewport Beach, California  92658
Texas OncologyDallas, Texas  
University of New MexicoAlbuquerque, New Mexico  87131
North Texas Regional Cancer CenterPlano, Texas  75075
University of Arkansas for Medical ScienceLittle Rock, Arkansas  72205
Rocky Mountain Cancer Center-MidtownDenver, Colorado  80218
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Bay Area Cancer Research Group, LLCConcord, California  94520
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Cancer Care of MaineBangor, Maine  04401
Lake Vista Cancer CenterLewisville, Texas  75067
Onc and Hem Associates of SW VA, Inc.Salem, Virginia  24153
Cancer Care Northwest-NorthSpokane, Washington  99218
University of Kansas HospitalKansas City, Kansas  66160
The Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Minnesota Oncology HematologyMinneapolis, Minnesota  55404
Paris Regional Cancer CenterParis, Texas  75460
Sarah Cannon Research InstituteNashville, Tennessee  37203
South Carolina Oncology Assoc., PAColumbia, South Carolina  29201
Cancer Care Centers of South Texas - HOASTSan Antonio, Texas  78229
Cookeville Regional Medical CenterCookeville, Tennessee  38501
Central Georgia Cancer Care, PCMacon, Georgia  31201
Kootenai Cancer CenterPost Falls, Idaho  83854
NH Oncology-Hematology PAHooksett, New Hampshire  03106
Interlakes Oncology Hematology, PCRochester, New York  14623
Connecticut Oncology & Hematology, LLPTorrington, Connecticut  06790
Advanced Medical SpecialtiesMiami, Florida  33176
Northwest Georgia Oncology Centers, PCMarietta, Georgia  30060
Watson Clinic LLPLakeland, Florida  33805
Mecklenburg Medical GroupCharlotte, North Carolina  
Cedars-Sinai Outpatient Cancer CenterLos Angeles, California  
City of Hope Nat`l Medical CenterDuarte, California  91010
USC/ Norris Comprehensive Cancer CenterLos Angeles, California  90033
USC/ Norris Comprehensive Cncer CenterLos Angeles, California  90033
University of California, San Francisco Comprehensive Cancer CenterSan Francisco, California  94143-1770
City of Hope Medical Group (COHMG)South Pasadena, California  91030
Rocky Mountain Cancer Center- AuroraAurora, Colorado  80012
Rocky Mountain Cancer Centers-BoulderBoulder, Colorado  80303
Rocky Mountain Cancer Centers- RoseDenver, Colorado  80220
Rocky Mountain Cancer Centers-LittletonLittleton, Colorado  80120-4413
Rocky Mountain Cancer Center-Sky RidgeLone Tree, Colorado  80124
Rocky Mountain Cancer Centers-LongmontLongmont, Colorado  80501
Rocky Mountain Cancer Center-ParkerParker, Colorado  80138
Rocky Mountain Cancer Centers-PuebloPueblo, Colorado  81008
Florida Cancer Institute-New HopeHudson, Florida  34667
Integrated Community Oncology Network, Division of Clinical ResearchJacksonville, Florida  32216
Florida Cancer Institute- New HopeNew Port Richey, Florida  34655
Cancer Centers of Florida, PPAOcoee, Florida  34761
Peachtree Hematology-Oncology Consultants, P.C.Atlanta, Georgia  30309
University of Chicago, Section of Hematology/Oncology MC2115Chicago, Illinois  60637
Joliet Oncology Hematology Assoc., LTDJoliet, Illinois  60435
Leonard J. Chabert Medical Center; PulmonaryHouma, Louisiana  70363
St. Joseph Medical Center`s Cancer InstituteTowson, Maryland  21204
St. Francis Medical CenterGrand Island, Nebraska  68803
NH Oncology-Hematology PA (Co)Concord, New Hampshire  03301
New Mexico Cancer Care, Cancer Institute of New MexicoSanta Fe, New Mexico  87505
St. Vincent Regional Cancer Care CenterSanta Fe, New Mexico  87505
The New York Presbyterian-Weill Medical College of Cornell UniversityNew York, New York  10065
State University of New York at Stony BrookStony Brook, New York  11794
Aultman Hospital/ North Canton Medical FoundationCanton, Ohio  44710
University Hopsitals of ClevelandCleveland, Ohio  44106
Hematology Oncology Consultants Inc.Columbus, Ohio  43228
Earle A Chiles Research InstitutePortland, Oregon  97213
Northwest Cancer Specialists, PCPortland, Oregon  97225
Cancer Care Associates - Mediacl OncologyBethlehem, Pennsylvania  18015
Allegheny General Hospital - Allegheny Singer Research InstitutePittsburg, Pennsylvania  15212
Cancer Centers of the Carolinas, SenecaSeneca, South Carolina  29672
Family Cancer Center, PLLCCollierville, Tennessee  38017
Texas Oncology, P.A. - AmarilloAmarillo, Texas  79106
Texas Oncology BeaumontBeaumont, Texas  77702-1449
Texas Oncology Texas Cancer Center at Medical CityDallas, Texas  75230-2510
Southwest Forth Worth Cancer CenterFort Worth, Texas  76132
Texas Oncology, Fort WorthFt. Worth, Texas  76104
Cancer Care Centers of South Texas-HOASTSan Antonio, Texas  78229
Texas Oncology -TylerTyler, Texas  75702
Texas Oncology Cancer Care and Researh CenterWaco, Texas  76712
Onc and Hem Assoc of SW VA, IncSalem, Virginia  24153
Univ. of Washington/ Seattle Cancer Care AllianceSeattle, Washington  98109
Cancer Care Northwest-ValleySpokane Valley, Washington  99216
Northwest Cancer Specialist, P.C.Vancouver, Washington  98686