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

Eli Lilly and Company30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

Cetuximab + GefitinibDRUG

IV solution + tablet, IV + oral, ERB (100 mg/m2, 200 mg/m2 + 250 mg/m2 IV) +GEF 250 mg tablet, ERB weekly/ GEF once daily, Until disease progression.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Local Institution

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Safe and effective dose of combination of Erbitux and Iressa therapy.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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