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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Erlotinib (tarceva)
Placebo
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Erlotinib, Tarceva, Web based, Stage III NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Hematology and Oncology Associates, LLC
  • Oncology Specialties, P.C.
  • Cooper Clinic
  • Genesis Cancer Center
  • Alta Bates Comprehensive Cancer Center
  • Northstate Cancer Speciality
  • Mercy General Hospital
  • St. Francis Hospital Cancer Center
  • Connecticut Oncology Group
  • George Bray Cancer Center/New Britain General Hospital
  • Oncology and Hematology Associates, PC
  • Whittingham Cancer Center at Norwalk Hospital
  • Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center
  • Washington Cancer Institute
  • Pasco Hernando Oncology Associates
  • Florida Cancer Specialists
  • Lee Cancer Clinic
  • Jupiter Medical Center
  • Cancer Care of North Florida
  • Pasco/Hernando Oncology
  • Mid Florida Oncology
  • MD Anderson
  • Oncology & Hematology Association of West Broward
  • Palm Beach Cancer Institute
  • Alexian Brothers Hospital Network
  • Joliet Hematology Associates
  • Investigative Clinical Research of Indiana LLC
  • Howard Regional Health System
  • McFarland Clinic
  • Kentucky Cancer Clinic
  • Western Hematology Oncology
  • Maine Center for Cancer Medicine
  • Sinai Hospital of Baltimore
  • Union Memorial Hospital
  • Harbor View Cancer Center
  • Franklin Square Hospital Center
  • Frederick Smith, MD
  • Community Hematology Oncology
  • Lahey Clinic Medical Center
  • Fallon Clinic Hematology/ Oncology
  • Bay Medical Cancer Center
  • Southeast Nebraska Hematology/Oncology
  • Methodist Cancer Center
  • Nevada Cancer Research Foundation
  • Dartmouth-Hitchcock-Keene
  • Norris Cotton Cancer Center
  • The Center for Cancer and Hematologic Disease
  • Sussex County Medical Associates
  • Lincoln Hospital
  • Queens Medical Associates
  • Winthrop University Hospital
  • Hematology Oncology Associates of Rockland, PC
  • Southeastern Medical Oncology Center
  • Aultman Cancer Center
  • The Cleveland Clinic Foundation Hematology/Med Oncology
  • Legacy Good Samaritan
  • SCOA-SC Onc Assoc
  • VA Department of Hematology/Oncology
  • Hope Oncology
  • Blood and Cancer Center of East Texas
  • Tyler Hematology/Oncology
  • Veterans Administration Medical Center
  • Virginia Oncology Associates Research Program
  • Olympic Hematology/Oncology
  • Morgantown Internal Medicine Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
Percent of Participants Surviving 3 Years
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.
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.

Full Information

First Posted
September 7, 2005
Last Updated
September 4, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Sanofi, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00153803
Brief Title
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Sanofi, Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer, NSCLC
Keywords
Erlotinib, Tarceva, Web based, Stage III NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib (tarceva)
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 50 months
Title
Percent of Participants Surviving 3 Years
Time Frame
36 months
Title
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation
Description
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.
Time Frame
18 months
Title
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Rigas, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Oncology Specialties, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Cooper Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72913
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Northstate Cancer Speciality
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
St. Francis Hospital Cancer Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Connecticut Oncology Group
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
George Bray Cancer Center/New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Oncology and Hematology Associates, PC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Whittingham Cancer Center at Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Pasco Hernando Oncology Associates
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Lee Cancer Clinic
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Cancer Care of North Florida
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Pasco/Hernando Oncology
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Mid Florida Oncology
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
MD Anderson
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Oncology & Hematology Association of West Broward
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Alexian Brothers Hospital Network
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Joliet Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Investigative Clinical Research of Indiana LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Howard Regional Health System
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Western Hematology Oncology
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Maine Center for Cancer Medicine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Harbor View Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Frederick Smith, MD
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Community Hematology Oncology
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Fallon Clinic Hematology/ Oncology
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Bay Medical Cancer Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Southeast Nebraska Hematology/Oncology
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Dartmouth-Hitchcock-Keene
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
00000
Country
United States
Facility Name
Sussex County Medical Associates
City
Newton
State/Province
New Jersey
ZIP/Postal Code
07860
Country
United States
Facility Name
Lincoln Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Queens Medical Associates
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Hematology Oncology Associates of Rockland, PC
City
New York
State/Province
New York
ZIP/Postal Code
10956
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Aultman Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
The Cleveland Clinic Foundation Hematology/Med Oncology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Legacy Good Samaritan
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
SCOA-SC Onc Assoc
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
VA Department of Hematology/Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hope Oncology
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Blood and Cancer Center of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Tyler Hematology/Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Veterans Administration Medical Center
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
Virginia Oncology Associates Research Program
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Olympic Hematology/Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Morgantown Internal Medicine Group
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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