A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel

Lilly

Status and phase: Withdrawn; Phase 2

Conditions: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768131

CA225-322

Details and patient eligibility

About

The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
• No prior chemotherapy or anti-EGFR targeted therapy
• Sufficient tumor material for FISH testing
• Measurable disease (RECIST)
• ECOG performance status 0 or 1

Exclusion criteria

• Symptomatic or uncontrolled CNS metastases
• Inadequate hematologic function defined as ANC < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
• Inadequate hepatic function defined as total bilirubin > 1.25 x ULN, AST level > 1.5 x ULN, or alkaline phosphatase > 5.0 x ULN
• Inadequate renal function defined by a serum creatinine level > 1.5 x ULN

Trial design

0 participants in 4 patient groups

A1 FISH (+)

Experimental group

Treatment:

Drug: Cetuximab

Drug: Carboplatin

Drug: Paclitaxel

B1 FISH (+)

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

A2 FISH (-)

Experimental group

Treatment:

Drug: Cetuximab

Drug: Carboplatin

Drug: Paclitaxel

B2 FISH (-)

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Paclitaxel