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

Trial Information

A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab

Outcome Time Frame:

Every 6 weeks

Safety Issue:

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-322

NCT ID:

NCT00768131

Start Date:

October 2008

Completion Date: