Status:
TERMINATED
Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Ce...
Detailed Description
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 con...
Eligibility Criteria
Inclusion
- 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
- Small cell or carcinoid lung cancer
- Known Central Nervous System (CNS) metastasis
- Pre-existing auto-immune or antibody mediated diseases
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
839 Patients enrolled
Trial Details
Trial ID
NCT00254904
Start Date
November 1 2005
End Date
June 1 2008
Last Update
March 30 2015
Active Locations (120)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
3
Pfizer Investigational Site
Bakersfield, California, United States, 93309
4
Pfizer Investigational Site
Saint Joseph, Michigan, United States, 49085