A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Drug: Cetuximab + Gefitinib

• Registration Number: NCT00162318
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for subject with non small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects with advanced or metastatic non small cell lung cancer.
• Subjects should have had at least one prior chemotherapy with a platinum based therapy.

Exclusion Criteria

• Subjects are excluded from this study if they do not have non small cell lung cancer that is advanced or metastatic or have not had at least one prior platinum based chemotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Cetuximab + Gefitinib	-

Primary Outcome Measures

Name	Time	Method
Safe and effective dose of combination of Erbitux and Iressa therapy.

Secondary Outcome Measures

Name	Time	Method
Response will be measured by radiographic measurement of disease every 4 weeks.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Pittsburgh, Pennsylvania, United States