Randomized, Open-Label, Phase 3 Trial of Erlotinib Alone or in Combination with CP-751,871 in Patients with Advanced Non-Small Cell Lung Cancer of Non-Adenocarcinoma Histology

IRB-HSR# 14339
Service: Cancer | Category: Cancer (Oncology), Pulmonary/Respiratory
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: Thomas J. Harris, M.D.

Contact Information

Contact: Elaine Dube
Phone: 434.924.9199
E-mail: ed7y@virginia.edu

Clinical Trial Description

UVA Health System, Department of Medicine, Hematology/Oncology seeks: Women and men ages 18 and older with advanced non small cell lung cancer (NSCLC) of non-adenocarcinoma histology for research study.

The purpose of the study is to determine the effect of the experimental drug, CP-751,871, when given with erlotinib (Tarceva®) compared to the use of erlotinib alone. The study will attempt to determine if one of these two treatments is better at preventing the growth of cancer cells in patients with NSCLC of non adenocarcinoma histology. The study involves answering health questionnaires, blood draws, physical exams, tests for heart function (electrocardiogram), CT/MRI scans and taking an FDA approved chemotherapy agent. Depending on the treatment plan you receive, the study may also involve taking an experimental medicine. Your participation in this study will require approximately 37 study visits over one year. Each visit will last 1 to 4 hours. Your medical condition is followed every 4 weeks for 14 months after the study closes to new patient enrollment.

Study-related medications are provided free of charge.

Participant's insurance company will be billed for non-experimental medication, tests and procedures.

Compensation

No compensation is provided for this study.