Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: carboplatin + paclitaxel + bevacizumab + PF-3512676 (Drug); paclitaxel + carboplatin + bevacizumab (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer

Official title: A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Progression-free survival

Secondary outcome:

Time to Tumor Progression

Overall Objective Response Rate

Duration of Response

Overall Survival

Overall safety profile

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung

cancer

- ECOG Performance Status 0-1

- Measurable disease per RECIST criteria

Exclusion Criteria:

- Squamous cell, small cell, or carcinoid lung cancer

- CNS metastasis

- Pre-existing autoimmune or antibody mediated disease

- Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or

investigation drugs

Pfizer Investigational Site, Bessemer, Alabama 35022, United States

Pfizer Investigational Site, Birmingham, Alabama 32511, United States

Pfizer Investigational Site, Birmingham, Alabama 35205, United States

Pfizer Investigational Site, Birmingham, Alabama 35209, United States

Pfizer Investigational Site, Birmingham, Alabama 35213, United States

Pfizer Investigational Site, Birmingham, Alabama 35235, United States

Pfizer Investigational Site, Mobile, Alabama 36607, United States

Pfizer Investigational Site, Los Angeles, California 90033, United States

Pfizer Investigational Site, Fountain Valley, California 92708, United States

Pfizer Investigational Site, Cocoa Beach, Florida 32931, United States

Pfizer Investigational Site, Merritt Island, Florida 32952, United States

Pfizer Investigational Site, Rockledge, Florida 32955, United States

Pfizer Investigational Site, Titusville, Florida 32796, United States

Pfizer Investigational Site, Valdosta, Georgia 31602, United States

Pfizer Investigational Site, Joliet, Illinois 60432, United States

Pfizer Investigational Site, Joliet, Illinois 60435, United States

Pfizer Investigational Site, Baltimore, Maryland 21231, United States

Pfizer Investigational Site, Clinton, North Carolina 28382, United States

Pfizer Investigational Site, Goldsboro, North Carolina 27534, United States

Pfizer Investigational Site, Wilson, North Carolina 27893, United States

Pfizer Investigational Site, Pollocksville, North Carolina 28573, United States

Pfizer Investigational Site, Knoxville, Tennessee 37920, United States

Pfizer Investigational Site, Knoxville, Tennessee 37934, United States

Pfizer Investigational Site, Austin, Texas 78705, United States

Pfizer Investigational Site, Austin, Texas 78745, United States

Pfizer Investigational Site, Austin, Texas 78758, United States

Pfizer Investigational Site, Austin, Texas 78759, United States

Pfizer Investigational Site, Georgetown, Texas 78626, United States

To obtain contact information for a study center near you, click here.

Starting date: December 2005
Ending date: June 2009
Last updated: June 9, 2008