Trial Information

Summary: OSI Radiant: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Single-Agent Tarceva (Erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-Small Cell Lung Carcinoma who have EGFR Positive Tumors

Particpant:  You have been asked to participate in this research study because you have early stage non-small cell lung cancer (NSCLC), you have had the tumor removed and it has been tested and determined to be EGFR-positive by a laboratory test.  You may have also received chemotherapy that your doctor felt was needed.  The purpose of this study is to compare Tarceva to placebo (an identical tablet that contains no medicine) to answer the following questions:   

•           Does giving Tarceva to subjects with early stage lung cancer with EGFR-positive tumors keep the cancer from coming back? 

•           What are the most common side effects of Tarceva when given to subjects with early stage lung cancer?

•           Is there anything that can be measured in samples collected from subjects during the study which will help predict if others with NSCLC might benefit from taking Tarceva? 

Your participation in this study is expected to last up to 2 (two) years for treatment and 5 (years) for follow-up.

Blood Donor: You have been asked to participate in this optional research study because you are participating in the main study, “A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB IIIA Non small Cell Lung Carcinoma who have EGFR-positive Tumor.”  The purpose of this optional study is to collect a small sample of blood to see whether different characteristics in genes are associated with different responses to treatment.  Your participation in this study is expected to last one day because you only have to provide one blood sample for this optional research.

Tissue Donor:  You have been asked to participate in this research study because you have early stage NSCLC and you had your tumor removed when you had lung cancer surgery.  You are being asked to donate a sample of the tumor tissue that was removed to see if it is EGFR-positive by certain laboratory tests.  If your tumor tissue is EGFR-positive, you may be eligible to participate in the treatment portion of this study, for which you would be given a separate consent form.  Your participation in this portion of the study is expected to last about three weeks, which is the time required for test results to be returned to your study doctor.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: September 2, 2008 at 1:52:49 PM