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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768131

Enrollment

Registered

2008-10-07

Start date

2008-10-31

Completion date

2008-10-31

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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

Interventions

DRUGCetuximab

Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision

DRUGPaclitaxel

Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum

DRUGCarboplatin

Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Tumor response	Every 6 weeks
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026