Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
1 other identifier
interventional
143
2 countries
43
Brief Summary
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2006
Typical duration for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
February 14, 2011
CompletedAugust 9, 2012
August 1, 2012
3.2 years
February 17, 2006
October 5, 2010
August 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-month Progression-free Survival
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
6 months after first dose
Secondary Outcomes (5)
Progression-free Survival
Until time of disease progression, as assessed every 21 days (maximum 28.8 months)
Overall Survival at 12 Months
12 months from 1st dose
Overall Survival
From first study treatment until time of death (maximum 29.0 months)
Best Tumor Response
While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
Duration of Tumor Response
While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
Study Arms (2)
Erlotinib
EXPERIMENTAL150 mg erlotinib daily
Erlotinib + chemotherapy (intercalated)
EXPERIMENTALcarboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
Interventions
oral tablet
Eligibility Criteria
You may qualify if:
- Age \>= 18
- Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
- Radiologically measurable or evaluable disease No prior chemotherapy
- or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
- Tumor tissue block or fine needle aspirate
You may not qualify if:
- Any concurrent anticancer therapy or radiation
- Other active malignancy
- Uncontrolled brain metastases
- GI abnormalities
- Severe abnormalities of the cornea
- Significant cardiac disease
- Active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Central Hematology Oncology Medical Group Inc.
Alhambra, California, 91801, United States
Comprehensive Blood and Cancer Center(Part of TORI network)
Bakersfield, California, 93309, United States
Bay Area Cancer Research Group
Concord, California, 94520, United States
Virginia K. Crosson Cancer Center
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Long Beach, California, 90813-3244, United States
UCLA Medical Center
Los Angeles, California, 90095-7077, United States
North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
Northridge, California, 91325, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, 91767, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer CenterResearch Department
Denver, Colorado, 80218, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360-2910, United States
MD Anderson Cancer Ctr - Orlando
Orlando, Florida, 32806, United States
Gulfcoast Oncology Associates
Tampa, Florida, 33614, United States
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, 30045, United States
Central Georgia Cancer Care, P.C.
Macon, Georgia, 31201, United States
Rush-Presbyterian-St.Luke's Med Ctr
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Norton Healthcare, Inc.
Louisville, Kentucky, 40202, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Univ. of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Hematology Oncology Centers of Northern Rockies Research
Billings, Montana, 59101, United States
Alegent Healthcare
Omaha, Nebraska, 68124, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Hematology-Oncology Associates, SJ, PA - Virtua Health
Mount Holly, New Jersey, 08060, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Pottsville Cancer Clinic
Pottsville, Pennsylvania, 17901, United States
Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.
Memphis, Tennessee, 38104, United States
The West Cancer Clinic
Memphis, Tennessee, 38120, United States
ACORN
Memphis, Tennessee, 38138, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, 23320, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
CR UK
Cambridge, CB2 2RE, United Kingdom
Peterborough District Hospital
Cambridge, PE3 6DA, United Kingdom
Beatson Oncology Centre
Glasgow, G11 6NT, United Kingdom
Mount Vernon Hospital
Middlesex, HA6 2RN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 22, 2006
Study Start
January 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 9, 2012
Results First Posted
February 14, 2011
Record last verified: 2012-08