Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
18 Years
N/A
Both
Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Carcinoma, Adenosquamous Cell
Trial Information
Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety
Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to
erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall
survival when compared to erlotinib alone.
This Oncology study continues as terminated, however for ethical reasons some patients,
noted with resultant benefit, continue receiving treatment.
Inclusion Criteria:
- Non small cell lung cancer with a primary histology of squamous cell, large cell or
adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.
Exclusion Criteria:
- Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
- Prior Erlotinib therapy.
- Prior anti IGF IR based investigational therapy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
50 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4021018
NCT ID:
NCT00673049
Start Date:
May 2008
Completion Date:
April 2012
Related Keywords:
- Carcinoma, Large Cell
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Squamous Cell
- Carcinoma, Adenosquamous Cell
- IGR-1R
- Non small cell lung cancer
- CP-751
- 871
- Figitumumab
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Squamous Cell
- Lung Neoplasms
- Carcinoma, Adenosquamous
- Carcinoma, Large Cell
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
| Pfizer Investigational Site | Billings, Montana 59101 |
| Pfizer Investigational Site | Lebanon, New Hampshire 03766 |
| Pfizer Investigational Site | Cheyenne, Wyoming 82001 |
| Pfizer Investigational Site | Morgantown, West Virginia 26506 |
