International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the
trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis)
also contributing to the decision. Subjects were allowed to complete standard of care
treatment/survival follow-up. Data collection was completed on 17 July 2008.
Inclusion Criteria:
- Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage
IV
- No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy,
immunotherapy, biologic response modifiers or other investigational drugs
- Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1
Exclusion Criteria:
- Small cell or carcinoid lung cancer
- Known Central Nervous System (CNS) metastasis
- Pre-existing auto-immune or antibody mediated diseases
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:
656 Events
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:
A8501001
NCT ID:
NCT00254891
Start Date:
November 2005
Completion Date:
July 2008
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| 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 | Federal Way, Washington 98003 |
| Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Las Vegas, Nevada 89128 |
| Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
| Pfizer Investigational Site | Burlington, Vermont 05401-3456 |
| Pfizer Investigational Site | Salt Lake City, Utah 84112 |
| Pfizer Investigational Site | Anchorage, Alaska 99508 |
| Pfizer Investigational Site | Bangor, Maine 04401 |
