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CompletedNCT00321815Updated Dec 23, 2010

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

A Phase 2 interventional study of PF-3512676 + Erlotinib and Erlotinib in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Completed at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-23.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 43 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known CNS metastasis
  • Pre-existing autoimmune or antibody mediated disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    A

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

    Drug: PF-3512676 + Erlotinib

  • Active comparator
    B

    Standard of Care chemotherapy

    Drug: Erlotinib

Interventions

  • DrugPF-3512676 + Erlotinib

    Drug pages: ProMune · 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

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

    Also known as: Tarceva

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival

    Time frame: 50Events

Secondary outcomes

  1. Overall Safety Profile

    Time frame: 28 days post treatment

  2. Time to Tumor Progression

    Time frame: End of treatment

  3. Overall Objective Response Rate

    Time frame: Time of disease progression

  4. Duration of Response

    Time frame: Time of disease progression

  5. Overall Survival

    Time frame: Time of death

07

Study locations

35 sites
  • 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
08

References and documents

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. PubMed 23792641 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2006, a primary completion of Jun 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2006
First posted
May 4, 2006
Start
Aug 2006
Primary completionActual
Jun 2010
CompletionActual
Jun 2010
Results delay requested
Aug 9, 2010
Last update
Dec 23, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00321815
Lead sponsor
Pfizer
First posted
May 4, 2006
Start date
Aug 2006
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Dec 23, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: ProMune · Erlotinib

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