Recruiting now. Could you help by joining this study?
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1 Non-Small Cell Lung Cancer Recruiting now AstraZeneca is looking for men and women with locally advanced or metastatic non-small cell lung cancer (NSCLC) to join ATLANTIC, a clinical study to help investigate a new treatment for this disease Could you help by joining this study? What is a clinical study? A clinical study (or trial) is a scientific investigation of possible new treatments, or different versions or new uses of existing treatments. Clinical studies can help to find out whether a potential new treatment works against a particular kind of disease. Each study is highly regulated and approved by regulatory and ethical groups before it can begin. Every year, thousands of people take part in such carefully conducted trials. Systems are in place to ensure your personal and medical data are protected. What is the ATLANTIC study? ATLANTIC will investigate whether giving MEDI4736 to men and women with locally advanced or metastatic lung cancer will help stop their cancer from getting worse and allow them to live longer. MEDI4736 is a new type of treatment for lung cancer that targets a mechanism used by some cancers to evade your immune system. The ATLANTIC study will test whether MEDI4736 can help your immune system to attack the cancer. Page 1 of 5
2 What is MEDI4736? MEDI4736 is a new type of treatment for lung cancer, called an immunotherapy, and works by helping your own immune system to attack the cancer. MEDI4736 blocks the interaction between programmed death-1 receptor (PD-1) on your immune cells and programmed death-ligand 1 (PD-L1) on the lung cancer cells. By interfering with the PD-1 / PD-L1 interaction, MEDI4736 may improve the ability of your immune cells to recognize and destroy the lung cancer cells. PD-L1 is found on the cancer cells of approximately 1 in 3 people with lung cancer, so before treatment with MEDI4736 your study doctor will test a sample of your lung cancer (via a biopsy) for presence of PD-L1 and to confirm whether MEDI4736 treatment is right for you. What are PD-1 and PD-L1? PD-1 is a protein that is expressed on the cells of your immune system that under normal circumstances helps to stop your immune cells attacking your own body. When PD-1 on your immune cells binds to PD-L1 on your body s tissues, it tells your immune system not to attack. Some lung cancers, however, use PD-L1 as a way to avoid being recognized and attacked by your immune system. What does the study involve? If you join the ATLANTIC study, you will need to attend the clinic every 2 weeks for up to 12 months to receive a 60-minute intravenous infusion (IV drip) of MEDI4736. During the infusion, liquid MEDI4736 will slowly flow from a clear plastic infusion bag through the drip tubing and will enter your bloodstream through a needle inserted into one of your veins. At the study start, you will need to come into the clinic for assessments, including blood tests Page 2 of 5
3 and scans, to check on your general health and well-being. During the study there will be regular checks to see whether your cancer is improving, staying the same or getting worse. When you stop taking study treatment, you will be encouraged to stay in the ATLANTIC study and participate in the follow-up program. Participating in the follow-up program means that your study doctor will continue to monitor your progress and well-being at regular intervals. Will there be side effects? All medicines can have side effects. For MEDI4736, we are still learning about these side effects through our clinical studies. Your study doctor will discuss these side effects with you, before you agree to enter the study. Throughout the study, your study doctor will ask how you are feeling when taking study treatment. How might I benefit? Although it is hoped that MEDI4736 treatment will help you, this cannot be guaranteed. The ATLANTIC study does not include a placebo arm (dummy treatment that looks exactly like the study treatment but does not contain any active ingredients), so everyone who is enrolled will receive MEDI4736. In addition, your participation in this study will help scientists to better understand whether or not MEDI4736 can help other men and women in your situation in the future. Can I take part? To join the ATLANTIC study, men and women must: Be aged at least 18 years Page 3 of 5
4 Have been diagnosed with locally advanced or metastatic NSCLC (Stage IIIB/IV), OR Have NSCLC that has recurred (come back) or progressed (got worse) following different types of treatments (radiation therapy, surgical resection, or a combination of chemotherapy and radiation therapy for locally advanced disease) Have received at least two prior systemic treatments, of which one must have been chemotherapy including a platinum agent (such as carboplatin and cisplatin) Have a tumor that expresses PD-L1 Be willing and able to participate in the study by receiving the investigational treatment, MEDI4736, via an infusion in a vein (called an intravenous or IV infusion) in the arm every 2 weeks Be willing and able to attend clinic visits every 2 weeks Not be affected by an uncontrolled illness such as heart failure What if I want to take part? You will need to speak to your doctor about the ATLANTIC study if you are interested in taking part. If your doctor thinks you are potentially suitable, they should contact the nearest participating hospital to discuss if you can be invited for a clinic visit to make sure you fully meet the requirements to join the study. Please ask your doctor to look at the information on the MEDI4736 website: Alternatively, you can download the document in the Information for healthcare professionals section of the website to give to your doctor: Page 4 of 5
5 Is there anything else I need to know? Participation in the ATLANTIC study is entirely voluntary. If you decide not to join the study, you do not need to give a reason and this will not affect the care you receive from your doctor. If you decide to take part but change your mind, you can withdraw from the treatment or study at any time. Further information Further information about ATLANTIC can be found on the MEDI4736 patient website: If you are in the USA or Canada, you or your doctor can call the AstraZeneca Cancer Study Locator service toll free on to get more information about the ATLANTIC study, to see if you may qualify for one of the studies, and to find a study doctor near you. Alternatively, you can If you are outside those countries, please talk to your doctor about the ATLANTIC study and direct them to the information on the MEDI4736 patient website: Page 5 of 5
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