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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ImClone LLC
• Treatments: Cetuximab; Gemcitabine

Criteria

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.