Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00153803

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2014-04-30

Brief Summary

This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

Detailed Description

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-free survival time for these patients.

Conditions

Carcinoma, Non-Small-Cell Lung; Non-small Cell Lung Cancer; NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.

Group Type: EXPERIMENTAL

Erlotinib (tarceva)

Intervention Type: DRUG

Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.

2

Matched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Interventions

Erlotinib (tarceva)

Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.

Intervention Type: DRUG

Placebo

Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R Rigas, MD

Role: STUDY_CHAIR

Norris Cotton Cancer Center

Locations

Birmingham Hematology and Oncology Associates, LLC

Birmingham, Alabama, United States

Oncology Specialties, P.C.

Huntsville, Alabama, United States

Cooper Clinic

Fort Smith, Arkansas, United States

Genesis Cancer Center

Hot Springs, Arkansas, United States

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Northstate Cancer Speciality

Redding, California, United States

Mercy General Hospital

Sacramento, California, United States

St. Francis Hospital Cancer Center

Hartford, Connecticut, United States

Connecticut Oncology Group

Middletown, Connecticut, United States

George Bray Cancer Center/New Britain General Hospital

New Britain, Connecticut, United States

Oncology and Hematology Associates, PC

New London, Connecticut, United States

Whittingham Cancer Center at Norwalk Hospital

Norwalk, Connecticut, United States

Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center

Stamford, Connecticut, United States

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Pasco Hernando Oncology Associates

Brooksville, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Lee Cancer Clinic

Fort Myers, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Cancer Care of North Florida

Lake City, Florida, United States

Pasco/Hernando Oncology

New Port Richey, Florida, United States

Mid Florida Oncology

Orange City, Florida, United States

MD Anderson

Orlando, Florida, United States

Oncology & Hematology Association of West Broward

Tamarac, Florida, United States

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, United States

Joliet Hematology Associates

Joliet, Illinois, United States

Investigative Clinical Research of Indiana LLC

Indianapolis, Indiana, United States

Howard Regional Health System

Kokomo, Indiana, United States

McFarland Clinic

Ames, Iowa, United States

Kentucky Cancer Clinic

Hazard, Kentucky, United States

Western Hematology Oncology

Paducah, Kentucky, United States

Maine Center for Cancer Medicine

Scarborough, Maine, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Harbor View Cancer Center

Baltimore, Maryland, United States

Franklin Square Hospital Center

Baltimore, Maryland, United States

Frederick Smith, MD

Chevy Chase, Maryland, United States

Community Hematology Oncology

Olney, Maryland, United States

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Fallon Clinic Hematology/ Oncology

Worcester, Massachusetts, United States

Bay Medical Cancer Center

Bay City, Michigan, United States

Southeast Nebraska Hematology/Oncology

Lincoln, Nebraska, United States

Methodist Cancer Center

Omaha, Nebraska, United States

Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Dartmouth-Hitchcock-Keene

Keene, New Hampshire, United States

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

Sussex County Medical Associates

Newton, New Jersey, United States

Queens Medical Associates

Fresh Meadows, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Hematology Oncology Associates of Rockland, PC

New York, New York, United States

Lincoln Hospital

The Bronx, New York, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Aultman Cancer Center

Canton, Ohio, United States

The Cleveland Clinic Foundation Hematology/Med Oncology

Cleveland, Ohio, United States

Legacy Good Samaritan

Portland, Oregon, United States

SCOA-SC Onc Assoc

Columbia, South Carolina, United States

VA Department of Hematology/Oncology

Houston, Texas, United States

Hope Oncology

Richardson, Texas, United States

Blood and Cancer Center of East Texas

Tyler, Texas, United States

Tyler Hematology/Oncology

Tyler, Texas, United States

Veterans Administration Medical Center

White River Junction, Vermont, United States

Virginia Oncology Associates Research Program

Newport News, Virginia, United States

Olympic Hematology/Oncology

Bremerton, Washington, United States

Morgantown Internal Medicine Group

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

D-0410

Identifier Type: -

Identifier Source: org_study_id