Study Stopped
See Termination Reason in Detailed Description.
Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC
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
1 other identifier
interventional
23
1 country
29
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2005
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedSeptember 28, 2009
September 1, 2009
2.4 years
April 10, 2006
September 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
110 Events
Secondary Outcomes (5)
Time to Tumor Progression
End of treatment
Overall Objective Response Rate
Time of progressive disease
Duration of Response
Time of progression
Overall Survival
Time of death
Overall safety profile
28 days post treatment
Study Arms (2)
B
ACTIVE COMPARATORStandard of care chemotherapy
A
EXPERIMENTALStandard of care chemotherapy plus experimental intervention (PF-3512676)
Interventions
paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (29)
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
Fountain Valley, California, 92708, United States
Pfizer Investigational Site
Los Angeles, California, 90033, 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
Pollocksville, North Carolina, 28573, United States
Pfizer Investigational Site
Wilson, North Carolina, 27893, 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
Pfizer Investigational Site
San Marcos, Texas, 78666, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
December 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
September 28, 2009
Record last verified: 2009-09