Clinical trial NCT00321815: Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Advanced, EGFR-positive NSCLC
* ECOG Performance Status 0, 1 or 2
* Measurable disease

Exclusion Criteria:

* Known CNS metastasis
* Pre-existing autoimmune or antibody mediated disease

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 50Events
Secondary outcomes:
measure: Overall Safety Profile
timeFrame: 28 days post treatment
measure: Time to Tumor Progression
timeFrame: End of treatment
measure: Overall Objective Response Rate
timeFrame: Time of disease progression
measure: Duration of Response
timeFrame: Time of disease progression
measure: Overall Survival
timeFrame: Time of death
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Corona
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendora
country: United States
facility: Pfizer Investigational Site
state: California
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Pomona
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: Pfizer Investigational Site
state: California
city: San Mateo
country: United States
facility: Pfizer Investigational Site
state: California
city: West Covina
country: United States
facility: Pfizer Investigational Site
state: California
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Deerfield Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Mason City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Bridgeton
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Chesterfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kirkwood
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Somerville
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadephia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dalls
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.