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

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ClinicalTrials.gov Identifier: NCT00321815
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : December 23, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: PF-3512676 + Erlotinib Drug: Erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2006
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
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

Active Comparator: B
Standard of Care chemotherapy
Drug: Erlotinib
Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
Other Name: Tarceva

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 50Events ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321815

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00321815     History of Changes
Other Study ID Numbers: A8501006
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: December 23, 2010
Last Verified: December 2010

Keywords provided by Pfizer:
advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action