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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153803
• Other study ID #: D-0410
• Status: Completed
• Phase: Phase 3
• Start date: May 2005
• Est. completion date: April 2014

Study information

• Verified date: September 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	McFarland Clinic	Ames	Iowa
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Harbor View Cancer Center	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Bay Medical Cancer Center	Bay City	Michigan
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	Olympic Hematology/Oncology	Bremerton	Washington
United States	Lincoln Hospital	Bronx	New York
United States	Pasco Hernando Oncology Associates	Brooksville	Florida
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Aultman Cancer Center	Canton	Ohio
United States	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey
United States	Frederick Smith, MD	Chevy Chase	Maryland
United States	The Cleveland Clinic Foundation Hematology/Med Oncology	Cleveland	Ohio
United States	SCOA-SC Onc Assoc	Columbia	South Carolina
United States	Alexian Brothers Hospital Network	Elk Grove Village	Illinois
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Lee Cancer Clinic	Fort Myers	Florida
United States	Cooper Clinic	Fort Smith	Arkansas
United States	Queens Medical Associates	Fresh Meadows	New York
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	St. Francis Hospital Cancer Center	Hartford	Connecticut
United States	Kentucky Cancer Clinic	Hazard	Kentucky
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	VA Department of Hematology/Oncology	Houston	Texas
United States	Oncology Specialties, P.C.	Huntsville	Alabama
United States	Investigative Clinical Research of Indiana LLC	Indianapolis	Indiana
United States	Joliet Hematology Associates	Joliet	Illinois
United States	Jupiter Medical Center	Jupiter	Florida
United States	Dartmouth-Hitchcock-Keene	Keene	New Hampshire
United States	Howard Regional Health System	Kokomo	Indiana
United States	Cancer Care of North Florida	Lake City	Florida
United States	Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Southeast Nebraska Hematology/Oncology	Lincoln	Nebraska
United States	Connecticut Oncology Group	Middletown	Connecticut
United States	Winthrop University Hospital	Mineola	New York
United States	Morgantown Internal Medicine Group	Morgantown	West Virginia
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	Pasco/Hernando Oncology	New Port Richey	Florida
United States	Hematology Oncology Associates of Rockland, PC	New York	New York
United States	Virginia Oncology Associates Research Program	Newport News	Virginia
United States	Sussex County Medical Associates	Newton	New Jersey
United States	Whittingham Cancer Center at Norwalk Hospital	Norwalk	Connecticut
United States	Community Hematology Oncology	Olney	Maryland
United States	Methodist Cancer Center	Omaha	Nebraska
United States	Mid Florida Oncology	Orange City	Florida
United States	MD Anderson	Orlando	Florida
United States	Western Hematology Oncology	Paducah	Kentucky
United States	Legacy Good Samaritan	Portland	Oregon
United States	Northstate Cancer Speciality	Redding	California
United States	Hope Oncology	Richardson	Texas
United States	Mercy General Hospital	Sacramento	California
United States	Maine Center for Cancer Medicine	Scarborough	Maine
United States	Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center	Stamford	Connecticut
United States	Oncology & Hematology Association of West Broward	Tamarac	Florida
United States	Blood and Cancer Center of East Texas	Tyler	Texas
United States	Tyler Hematology/Oncology	Tyler	Texas
United States	Washington Cancer Institute	Washington	District of Columbia
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Veterans Administration Medical Center	White River Junction	Vermont
United States	Fallon Clinic Hematology/ Oncology	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Genentech, Inc., Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival		From date of randomization until the date of death from any cause, assessed up to 50 months
Secondary	Percent of Participants Surviving 3 Years		36 months
Secondary	Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation	Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.	18 months
Secondary	Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo	Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.	18 months