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Completed

NCT Number: NCT00321815

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Daphne, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-3512676 + Erlotinib

Drug

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

Drug

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

Other names: Tarceva

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 4, 2006
Registry last updated
Dec 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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