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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Daphne, Alabama, 36526 United States
Contact
1-800-718-1021
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

NCT00321815
Pfizer
Completed
Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
  • 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
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.
 
Completed
43
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00321815
A8501006
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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