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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
• Interventions: Drug: Cetuximab

• Registration Number: NCT00207116
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Cetuximab	-

Primary Outcome Measures

Name	Time	Method
Prediction of response to Erbitux with non small cell lung cancer

Secondary Outcome Measures

Name	Time	Method
Radiographic Response

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Newark, Delaware, United States