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

NCT00153803 | Completed Phase 3 Results DMC

• 1 other identifier: D-0410
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 65

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).

Conditions

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

Keywords

Erlotinib; Tarceva; Web based; Stage III NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.

  5 years

Secondary Outcomes (4)

• Overall Survival

  From date of randomization until the date of death from any cause, assessed up to 50 months

• Percent of Participants Surviving 3 Years

  36 months

• Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation

  18 months

• Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo

  18 months

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: Erlotinib (tarceva)

2

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Erlotinib (tarceva) 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.

1

Placebo 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Metastasis
• Prior treatment
• Malignant pleural or pericardial effusion
• Peripheral neuropathy \>= grade 2

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Sanofi: collaborator
• Genentech, Inc.: collaborator

Study Sites (65)

Birmingham Hematology and Oncology Associates, LLC

Birmingham, Alabama, 35235, United States

Location

Oncology Specialties, P.C.

Huntsville, Alabama, 35801, United States

Location

Cooper Clinic

Fort Smith, Arkansas, 72913, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Northstate Cancer Speciality

Redding, California, 96001, United States

Location

Mercy General Hospital

Sacramento, California, 95816, United States

Location

St. Francis Hospital Cancer Center

Hartford, Connecticut, 06105, United States

Location

Connecticut Oncology Group

Middletown, Connecticut, 06457, United States

Location

George Bray Cancer Center/New Britain General Hospital

New Britain, Connecticut, 06050, United States

Location

Oncology and Hematology Associates, PC

New London, Connecticut, 06320, United States

Location

Whittingham Cancer Center at Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center

Stamford, Connecticut, 06902, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Pasco Hernando Oncology Associates

Brooksville, Florida, 34613, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Lee Cancer Clinic

Fort Myers, Florida, 33919, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Cancer Care of North Florida

Lake City, Florida, 32055, United States

Location

Pasco/Hernando Oncology

New Port Richey, Florida, 34652, United States

Location

Mid Florida Oncology

Orange City, Florida, 32763, United States

Location

MD Anderson

Orlando, Florida, 32806, United States

Location

Oncology & Hematology Association of West Broward

Tamarac, Florida, 33321, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, 33410, United States

Location

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

Location

Joliet Hematology Associates

Joliet, Illinois, 60435, United States

Location

Investigative Clinical Research of Indiana LLC

Indianapolis, Indiana, 46254, United States

Location

Howard Regional Health System

Kokomo, Indiana, 46904, United States

Location

McFarland Clinic

Ames, Iowa, 50010, United States

Location

Kentucky Cancer Clinic

Hazard, Kentucky, 41701, United States

Location

Western Hematology Oncology

Paducah, Kentucky, 42003, United States

Location

Maine Center for Cancer Medicine

Scarborough, Maine, 04074, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Harbor View Cancer Center

Baltimore, Maryland, 21225, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Frederick Smith, MD

Chevy Chase, Maryland, 20815, United States

Location

Community Hematology Oncology

Olney, Maryland, 20832, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

Fallon Clinic Hematology/ Oncology

Worcester, Massachusetts, 01608, United States

Location

Bay Medical Cancer Center

Bay City, Michigan, 48706, United States

Location

Southeast Nebraska Hematology/Oncology

Lincoln, Nebraska, 68510, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Dartmouth-Hitchcock-Keene

Keene, New Hampshire, 03431, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, 00000, United States

Location

Sussex County Medical Associates

Newton, New Jersey, 07860, United States

Location

Queens Medical Associates

Fresh Meadows, New York, 11365, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Hematology Oncology Associates of Rockland, PC

New York, New York, 10956, United States

Location

Lincoln Hospital

The Bronx, New York, 10451, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Aultman Cancer Center

Canton, Ohio, 44710, United States

Location

The Cleveland Clinic Foundation Hematology/Med Oncology

Cleveland, Ohio, 44195, United States

Location

Legacy Good Samaritan

Portland, Oregon, 97201, United States

Location

SCOA-SC Onc Assoc

Columbia, South Carolina, 29201, United States

Location

VA Department of Hematology/Oncology

Houston, Texas, 77030, United States

Location

Hope Oncology

Richardson, Texas, 75080, United States

Location

Blood and Cancer Center of East Texas

Tyler, Texas, 75701, United States

Location

Tyler Hematology/Oncology

Tyler, Texas, 75701, United States

Location

Veterans Administration Medical Center

White River Junction, Vermont, 05009, United States

Location

Virginia Oncology Associates Research Program

Newport News, Virginia, 23606, United States

Location

Olympic Hematology/Oncology

Bremerton, Washington, 98310, United States

Location

Morgantown Internal Medicine Group

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Research Office
• Organization: Dartmouth-Hitchcock Medical Center

Cancer.Research.Nurse@Dartmouth.edu

Study Officials

• James R Rigas, MD

  Norris Cotton Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Locations

US (65)