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

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NCT00321815

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Study Location
Pfizer Investigational Site
Daphne, Alabama, 36526, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Advanced, EGFR-positive NSCLC

- ECOG Performance Status 0, 1 or 2

- Measurable disease

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Known CNS metastasis


- Pre-existing autoimmune or antibody mediated disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: 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

  • Drug: Erlotinib
    Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
    Other Name: Tarceva
Study Arms  ICMJE
  • Experimental: A
    Standard of Care chemotherapy plus experimental intervention (PF-3512676)
    Intervention: Drug: PF-3512676 + Erlotinib
  • Active Comparator: B
    Standard of Care chemotherapy
    Intervention: Drug: Erlotinib
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2010)		43
Original Enrollment  ICMJE
 (submitted: May 3, 2006)		130
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00321815
Other Study ID Numbers  ICMJE A8501006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP