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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.