Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

Stopped early · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.

Key facts

Study ID

NCT00254904

Run by

Pfizer

People needed

839

Starts

2005-11-01

Expected to finish

2008-06-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Small cell or carcinoid lung cancer
• Known Central Nervous System (CNS) metastasis
• Pre-existing auto-immune or antibody mediated diseases

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Bakersfield, California, United States
• Pfizer Investigational Site — Saint Joseph, Michigan, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Spokane, Washington, United States
• Pfizer Investigational Site — Spokane, Washington, United States
• Pfizer Investigational Site — Innsbruck, Austria
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Charleroi, Belgium
• Pfizer Investigational Site — Hasselt, Belgium
• Pfizer Investigational Site — Jette, Belgium
• Pfizer Investigational Site — Leuven, Belgium
• Pfizer Investigational Site — Liège, Belgium
• Pfizer Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Pfizer Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Pfizer Investigational Site — Jaú, São Paulo, Brazil
• Pfizer Investigational Site — Jaú, São Paulo, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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