CompletedPhase 2NCT00112346

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

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.

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

StatusCompleted
PhasePhase 2
U.S. locations38
SponsorEli Lilly and Company
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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. Exclusion 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.

04
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.

View original record ↗