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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: May 3, 2006
Last updated: December 16, 2010
Last verified: December 2010
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 Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: PF-3512676 + Erlotinib Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • Overall Safety Profile [ Time Frame: 28 days post treatment ]
  • Time to Tumor Progression [ Time Frame: End of treatment ]
  • Overall Objective Response Rate [ Time Frame: Time of disease progression ]
  • Duration of Response [ Time Frame: Time of disease progression ]
  • Overall Survival [ Time Frame: Time of death ]

Enrollment: 43
Study Start Date: August 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00321815

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00321815     History of Changes
Other Study ID Numbers: A8501006
Study First Received: May 3, 2006
Last Updated: December 16, 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 processed this record on September 21, 2017