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

Phase 2

Withdrawn

• Conditions: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00768131
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2 FISH (-)	Cetuximab	-
A1 FISH (+)	Cetuximab	-
A1 FISH (+)	Paclitaxel	-
A1 FISH (+)	Carboplatin	-
B1 FISH (+)	Paclitaxel	-
B1 FISH (+)	Carboplatin	-
A2 FISH (-)	Paclitaxel	-
A2 FISH (-)	Carboplatin	-
B2 FISH (-)	Paclitaxel	-
B2 FISH (-)	Carboplatin	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab	Every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Disease control	Every 6 weeks
Overall survival (OS)	Every 4 months after subject off-treatment until 1 year after LPLT
Duration of Response	Every 6 weeks
Safety & exploratory biomarker analysis	Every 3 weeks
Tumor response	Every 6 weeks

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Austin, Texas, United States