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Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

NCT ID: NCT00321815

Last Updated: 2010-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Standard of Care chemotherapy plus experimental intervention (PF-3512676)

Group Type EXPERIMENTAL

PF-3512676 + Erlotinib

Intervention Type DRUG

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

B

Standard of Care chemotherapy

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity

Interventions

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PF-3512676 + Erlotinib

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

Intervention Type DRUG

Erlotinib

Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Daphne, Alabama, United States

Site Status

Pfizer Investigational Site

Huntsville, Alabama, United States

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Pfizer Investigational Site

Mobile, Alabama, United States

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Pfizer Investigational Site

Corona, California, United States

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Pfizer Investigational Site

Glendora, California, United States

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Pfizer Investigational Site

Greenbrae, California, United States

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Pfizer Investigational Site

Pasadena, California, United States

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Pfizer Investigational Site

Pomona, California, United States

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Pfizer Investigational Site

Rancho Cucamonga, California, United States

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Pfizer Investigational Site

San Mateo, California, United States

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Pfizer Investigational Site

West Covina, California, United States

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Pfizer Investigational Site

Norwalk, Connecticut, United States

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Pfizer Investigational Site

Deerfield Beach, Florida, United States

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Pfizer Investigational Site

Melbourne, Florida, United States

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Pfizer Investigational Site

Miami, Florida, United States

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Pfizer Investigational Site

Munster, Indiana, United States

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Pfizer Investigational Site

Mason City, Iowa, United States

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Pfizer Investigational Site

Crestview Hills, Kentucky, United States

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Pfizer Investigational Site

Louisville, Kentucky, United States

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Pfizer Investigational Site

Bridgeton, Missouri, United States

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Pfizer Investigational Site

Chesterfield, Missouri, United States

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Pfizer Investigational Site

Kirkwood, Missouri, United States

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Pfizer Investigational Site

Somerville, New Jersey, United States

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Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

Stony Brook, New York, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Fairfield, Ohio, United States

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Pfizer Investigational Site

Hershey, Pennsylvania, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

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Pfizer Investigational Site

Philadephia, Pennsylvania, United States

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Pfizer Investigational Site

Kingsport, Tennessee, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Dalls, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23792641 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8501006&StudyName=Trial%20Of%20Erlotinib%20With%20Or%20Without%20PF-3512676%20In%20%20Advanced%20Non%20Small%20Cell%20Lung%20Cancer%0A

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

Other Identifiers

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A8501006

Identifier Type: -

Identifier Source: org_study_id