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A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).

Phase 3
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer, NSCLC

Thank you

Trial Information

A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).

The promising activity of erlotinib as a single agent in advanced refractory NSCLC along
with its oral administration and favorable adverse event profile makes this agent an
excellent candidate to incorporate into combined modality therapy in the early stages of
lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance
therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation.
Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors
following chemotherapy and thoracic radiation therapy, the vast majority relapse within the
first year following therapy and eventually die from chemotherapy refractory disease. We
hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal
growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and
carboplatin will prolong the progression-three survival time for these patients.

Inclusion Criteria:

- Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)

- No evidence of metastatic disease

- No prior treatment

- Adequate organ function

- Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

Exclusion Criteria:

- Metastasis

- Prior treatment

- Malignant pleural or pericardial effusion

- Peripheral neuropathy >= grade 2

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

James R Rigas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

July 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer
  • Erlotinib
  • Tarceva
  • Web based
  • Stage III NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Sinai Hospital of Baltimore Baltimore, Maryland  21225
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
Franklin Square Hospital Center Baltimore, Maryland  21237
Aultman Cancer Center Canton, Ohio  44710
Nevada Cancer Research Foundation Las Vegas, Nevada  89109
Winthrop University Hospital Mineola, New York  11501
Florida Cancer Specialists Fort Myers, Florida  33901
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Washington Cancer Institute Washington, District of Columbia  20010
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Southeastern Medical Oncology Center Goldsboro, North Carolina  27534
Whittingham Cancer Center at Norwalk Hospital Norwalk, Connecticut  06856
Genesis Cancer Center Hot Springs, Arkansas  71913
Morgantown Internal Medicine Group Morgantown, West Virginia  26505
Union Memorial Hospital Baltimore, Maryland  21218
Mercy General Hospital Sacramento, California  95819
The Center for Cancer and Hematologic Disease Cherry Hill, New Jersey  08003
Methodist Cancer Center Omaha, Nebraska  68114
Pasco Hernando Oncology Associates New Port Richey, Florida  34652
Hope Oncology Richardson, Texas  75080
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Connecticut Oncology Group Middletown, Connecticut  06457
McFarland Clinic Ames, Iowa  50010
Queens Medical Associates Fresh Meadows, New York  11365
Birmingham Hematology and Oncology Associates, LLC Birmingham, Alabama  35235
Maine Center for Cancer Medicine Scarborough, Maine  04074
Blood and Cancer Center of East Texas Tyler, Texas  75701
Jupiter Medical Center Jupiter, Florida  33458
Lee Cancer Clinic Fort Myers, Florida  33919
Oncology Specialties, P.C. Huntsville, Alabama  35801
Cooper Clinic Fort Smith, Arkansas  72913
Northstate Cancer Speciality Redding, California  96001
St. Francis Hospital Cancer Center Hartford, Connecticut  06105
George Bray Cancer Center/New Britain General Hospital New Britain, Connecticut  06050
Oncology and Hematology Associates, PC New London, Connecticut  06320
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center Stamford, Connecticut  06902
Cancer Care of North Florida Lake City, Florida  32055
Pasco/Hernando Oncology New Port Richey, Florida  34652
Mid Florida Oncology Orange City, Florida  32763
MD Anderson Orlando, Florida  32806
Oncology & Hematology Association of West Broward Tamarac, Florida  33321
Alexian Brothers Hospital Network Elk Grove Village, Illinois  60007
Joliet Hematology Associates Joliet, Illinois  60435
Investigative Clinical Research of Indiana LLC Indianapolis, Indiana  46254
Howard Regional Health System Kokomo, Indiana  46904
Western Hematology Oncology Paducah, Kentucky  42003
Harbor View Cancer Center Baltimore, Maryland  21225
Frederick Smith, MD Chevy Chase, Maryland  20815
Community Hematology Oncology Olney, Maryland  20832
Lahey Clinic Medical Center Burlington, Massachusetts  01805
Fallon Clinic Hematology/ Oncology Worcester, Massachusetts  01608
Bay Medical Cancer Center Bay City, Michigan  48706
Southeast Nebraska Hematology/Oncology Lincoln, Nebraska  68510
Dartmouth-Hitchcock-Keene Keene, New Hampshire  03431
Sussex County Medical Associates Newton, New Jersey  07860
Lincoln Hospital Bronx, New York  10451
Hematology Oncology Associates of Rockland, PC New York City, New York  10956
The Cleveland Clinic Foundation Hematology/Med Oncology Cleveland, Ohio  44195
Legacy Good Samaritan Portland, Oregon  97201
SCOA-SC Onc Assoc Columbia, South Carolina  29201
VA Department of Hematology/Oncology Houston, Texas  77030
Tyler Hematology/Oncology Tyler, Texas  75701
Veterans Administration Medical Center White River Junction, Vermont  05009
Virginia Oncology Associates Research Program Newport News, Virginia  23606
Olympic Hematology/Oncology Bremerton, Washington  98310