Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Study summary

The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCetuximab + platinum + gemcitabine and Platinum + Gemcitabine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?38 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: Cetuximab + platinum + gemcitabine; Drug: Platinum + Gemcitabine

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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)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

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

Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.

Reasons someone may not be able to joinExclusion criteria

Women who are pregnant or breastfeeding.
Women with a positive pregnancy test on enrollment or prior to study drug administration.
Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
Symptomatic or uncontrolled metastases in the central nervous system (CNS).
Peripheral neuropathy.
Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dL.
Inadequate liver function.
Inadequate kidney function.

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

Study sites

U.S. locations

Local InstitutionMobile, Alabama
Local InstitutionAnchorage, Alaska
Local InstitutionBakersfield, California
Local InstitutionCorona, California
Local InstitutionOxnard, California
Local InstitutionSan Diego, California
Local InstitutionWhittier, California
Local InstitutionLakewood, Colorado
Local InstitutionBoynton Beach, Florida
Local InstitutionBrooksville, Florida
Local InstitutionInverness, Florida
Local InstitutionPembroke Pines, Florida

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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