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WithdrawnPhase 2NCT00768131
Official study title

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

Study 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

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedCetuximab and Paclitaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 28, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Interventional
Phase
Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
EGFR→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Local InstitutionLittle Rock, Arkansas
  • Local InstitutionLong Beach, California
  • Local InstitutionBoynton Beach, Florida
  • Local InstitutionChicago, Illinois
  • Local InstitutionSkokie, Illinois
  • Local InstitutionWichita, Kansas
  • Local InstitutionLouisville, Kentucky
  • Local InstitutionMount Sterling, Kentucky
  • Local InstitutionAnnapolis, Maryland
  • Local InstitutionKalamazoo, Michigan
  • Local InstitutionStaten Island, New York
  • Local InstitutionWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2015. Always confirm current availability with the study team.

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