An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Overview

The purpose of this study is to predict responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2006

Interventions

  • Drug: Cetuximab
    • IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.

Arms, Groups and Cohorts

  • Experimental: A

Clinical Trial Outcome Measures

Primary Measures

  • Prediction of response to Erbitux with non small cell lung cancer

Secondary Measures

  • Radiographic Response

Participating in This Clinical Trial

Inclusion Criteria

  • Measurable disease tumor available for biopsies – Life expectancy of at least 3 months Exclusion Criteria:

  • Known or documented brain metastases prior to Cetuximab therapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST), Study Director, Eli Lilly and Company

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