Trial Information

PHII-120: Randomized Phase II Study of AZD6244 (mitogen-activated protein kinase inhibitor) MEK-Inhibitor with erlotinib in KRAS wild type Advanced Non-Small Cell Lung Cancer(NSCLC) and a Randomized Phase II Study of AZD6244 with Erlotinib in mutant KRAS Advanced NSCLC

You have been asked to participate in this research study because you have been diagnosed with advanced Non-Small Cell Lung Cancer (NSCLC) and your cancer has grown during or after previous treatment. The purpose of this study is to see whether the investigational drug AZD6244, can keep your cancer from growing for a longer period of time as compared to the currently available oral agent, erlotinib, which is considered to be standard of care after a patient has received first line chemotherapy for Non Small Cell Lung Cancer (NSCLC). Standard of care means that this is medical treatment that you would be likely to receive whether you were in this study or not. Other purposes of study are to see whether research participants taking AZD6244 will live longer when AZD6244 is combined with erlotinib. We will evaluate AZD6244 and the combination of AZD6244 with erlotinib for safety and to determine if the side effects are similar to those experienced when taking only erlotinib. In addition, we will evaluate if AZD6244 can keep tumors with mutations in KRAS (see below) from growing. The anticipated length of the entire study is 3 years. Your treatment on this study is expected to last for as long as your tumor is not growing and you are not having any unmanageable side effects. After your treatment on this study is over, your medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

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

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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Research Center Information: City of Hope

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