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

Lilly

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell Lung Carcinoma

Treatments

Drug: Cetuximab + platinum + gemcitabine

Drug: Platinum + Gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00112346

CA225-100

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.