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

Completed · Phase 2

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT00112346

Run by

Eli Lilly and Company

People needed

120

Starts

2005-01-01

Expected to finish

2006-12-01

Last updated by the study team

2015-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution — Mobile, Alabama, United States
• Local Institution — Anchorage, Alaska, United States
• Local Institution — Bakersfield, California, United States
• Local Institution — Corona, California, United States
• Local Institution — Oxnard, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Whittier, California, United States
• Local Institution — Lakewood, Colorado, United States
• Local Institution — Boynton Beach, Florida, United States
• Local Institution — Brooksville, Florida, United States
• Local Institution — Inverness, Florida, United States
• Local Institution — Pembroke Pines, Florida, United States
• Local Institution — Austell, Georgia, United States
• Local Institution — Honolulu, Hawaii, United States
• Local Institution — Skokie, Illinois, United States
• Local Institution — Muncie, Indiana, United States
• Local Institution — Annapolis, Maryland, United States
• Local Institution — Frederick, Maryland, United States
• Local Institution — Rockville, Maryland, United States
• Local Institution — Plymouth, Massachusetts, United States
• Local Institution — Farmington, New Mexico, United States
• Local Institution — Armonk, New York, United States
• Local Institution — Stony Brook, New York, United States
• Local Institution — Gastonia, North Carolina, United States
• Local Institution — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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