Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer
A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
1 other identifier
interventional
43
1 country
35
Brief Summary
To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2006
Typical duration for phase_2
35 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
First Submitted
Initial submission to the registry
May 3, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedDecember 23, 2010
December 1, 2010
3.8 years
May 3, 2006
December 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
50Events
Secondary Outcomes (5)
Overall Safety Profile
28 days post treatment
Time to Tumor Progression
End of treatment
Overall Objective Response Rate
Time of disease progression
Duration of Response
Time of disease progression
Overall Survival
Time of death
Study Arms (2)
A
EXPERIMENTALStandard of Care chemotherapy plus experimental intervention (PF-3512676)
B
ACTIVE COMPARATORStandard of Care chemotherapy
Interventions
PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- Advanced, EGFR-positive NSCLC
- ECOG Performance Status 0, 1 or 2
- Measurable disease
You may not qualify if:
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (35)
Pfizer Investigational Site
Daphne, Alabama, 36526, United States
Pfizer Investigational Site
Huntsville, Alabama, 35805, United States
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Pfizer Investigational Site
Corona, California, 92879, United States
Pfizer Investigational Site
Glendora, California, 91741, United States
Pfizer Investigational Site
Greenbrae, California, 94904, United States
Pfizer Investigational Site
Pasadena, California, 91105, United States
Pfizer Investigational Site
Pomona, California, 91767, United States
Pfizer Investigational Site
Rancho Cucamonga, California, 91730, United States
Pfizer Investigational Site
San Mateo, California, 94402, United States
Pfizer Investigational Site
West Covina, California, 91790, United States
Pfizer Investigational Site
Norwalk, Connecticut, 06856, United States
Pfizer Investigational Site
Deerfield Beach, Florida, 33442, United States
Pfizer Investigational Site
Melbourne, Florida, 32901, United States
Pfizer Investigational Site
Miami, Florida, 33136, United States
Pfizer Investigational Site
Munster, Indiana, 46321, United States
Pfizer Investigational Site
Mason City, Iowa, 50401, United States
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
Bridgeton, Missouri, 63044, United States
Pfizer Investigational Site
Chesterfield, Missouri, 63017, United States
Pfizer Investigational Site
Kirkwood, Missouri, 63122, United States
Pfizer Investigational Site
Somerville, New Jersey, 08876, United States
Pfizer Investigational Site
New York, New York, 10016, United States
Pfizer Investigational Site
Stony Brook, New York, 11794, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45209, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Fairfield, Ohio, 45014, United States
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Pfizer Investigational Site
Philadephia, Pennsylvania, 19104, United States
Pfizer Investigational Site
Kingsport, Tennessee, 37660, United States
Pfizer Investigational Site
Dallas, Texas, 75230, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Dalls, Texas, 75246, United States
Related Publications (1)
Belani CP, Nemunaitis JJ, Chachoua A, Eisenberg PD, Raez LE, Cuevas JD, Mather CB, Benner RJ, Meech SJ. Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer. Cancer Biol Ther. 2013 Jul;14(7):557-63. doi: 10.4161/cbt.24598. Epub 2013 May 10.
PMID: 23792641DERIVED
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
May 3, 2006
First Posted
May 4, 2006
Study Start
August 1, 2006
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
December 23, 2010
Record last verified: 2010-12