International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin 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 Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin 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
(thrombocytopenia) also contributing to the decision. Subjects were allowed to complete
standard of care treatment/survival follow-up. Data collection was completed on 25 June
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 Group 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:
A8501002
NCT ID:
NCT00254904
Start Date:
November 2005
Completion Date:
June 2008
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
