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Have you been newly diagnosed with non-small cell lung cancer (NSCLC)? Learn if a clinical trial is right for you.
If you have been diagnosed with advanced or metastatic NSCLC or have a specific mutation in the epidermal growth factor receptor (EGFR) gene, the Copernicus clinical trial might be an option for you. The Copernicus clinical research study is evaluating the addition of an investigational medication to an oral medication and chemotherapy for NSCLC.
What is a clinical research study, and why is it important?
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medication. Clinical trials help doctors and researchers determine if an investigational medication is safe and/or effective for the treatment of a condition, disease, or disorder.
Clinical trials are completely optional, and each one has a specific set of criteria a participant must meet to join. Clinical studies, conducted by doctors and researchers, often require a large number of volunteers to participate in a single study, and sometimes thousands are needed to obtain reliable information.
What can I expect if I join a clinical trial?
If you qualify and choose to join a clinical trial, you will first sign an informed consent form (ICF). “Informed Consent” is a process of information exchange before an adult agrees to participate in a clinical trial. During this process, you will be asked to read the ICF, and a study doctor or member of the research team will explain all the details of the study and answer your questions.
By signing the ICF, you agree to volunteer to take part in the study, you understand the study procedures, risks, and potential side effects, and that you can leave the study at any time, for any reason. If you don’t understand what is expected of you or what is written in the document, you should continue to ask questions and talk with the study doctor, your family, or others that you trust, until you feel you understand.
What is the purpose of the Copernicus study?
The purpose of this clinical research study is to determine the safety and efficacy of the addition of an investigational medication in combination with another oral therapy or chemotherapy for adults who have been diagnosed with non-small cell lung cancer (NSCLC).
Am I eligible for the Copernicus study?
You may be able to participate in this study if you:
- Are 18 years of age or older
- Have been diagnosed with advanced or metastatic NSCLC
- Have a specific mutation in the epidermal growth factor receptor (EGFR) gene
Additional eligibility criteria will apply and be assessed by the study doctor or staff during the screening process. Screening will occur prior to being enrolled in the study and receiving any investigational medication. Not all individuals may qualify to participate in the research.
What can I expect if I join the Copernicus study?
- If you qualify and choose to join the study and sign the informed consent form (ICF), you will be asked to attend a screening visit with the study doctor to ensure you meet all eligibility criteria.
- Eligible patients will be placed in a study group. Participants will receive the investigational medication + oral study medication.
- The oral study medication is taken once a day by mouth. The investigational medication is given as an injection under the skin.
- The study medication will be given in recurring 28-day cycles.
- At study clinic visits, participants will have their health evaluated through various health exams and tests.
- Study participation may last up to about 3 years, as long as the participant wants to continue, and the study doctor believes it is safe.
What is expected during my participation in the Copernicus study?
Your study doctor and research staff will guide you throughout your participation in the study. However, you can expect the following general expectations:
- Tell the study doctor/staff about any health problems you have during the study.
- Come to all study visit appointments.
- Ask the study doctor/staff any questions you have about the study.
- Tell the study doctor/staff about any new medicine you take during the study, as well as any changes to your medicines.
How do I learn more about participation in the Copernicus study?
You can talk to your doctor to find out if you are a candidate for a clinical trial. Click here to visit the study page and learn more about the Copernicus study.
Where can I go to learn more about NSCLC?
There are several online resources available. For further information and research support groups, consider visiting the following websites. Consider asking your doctor if they can recommend local support groups near you.
This article is brought to you by Janssen.
