Purpose of this Study
We are doing this research study to learn about the safety and effectiveness of alirocumab (a cholesterol-lowering drug) when it is combined with cemiplimab (an immunotherapy drug) and preoperative chemotherapy in patients with stage 1B-3A non-small cell lung cancer (NSCLC) who will undergo surgery. This study is important because it might potentially improve outcomes for you and other future patients.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have a diagnosis of stage1B-3A NSCLC</li>
<li>Meet specific diagnostic criteria relating to your disease</li>
<li>Are a candidate for surgery to treat your disease</li>
<li>Agree to have your blood drawn for research</li>
<li>Have not had any chemotherapy, radiation therapy, or biologic/targeted therapy for your current diagnosis</li>
<li>Have not had any other invasive cancers in the past 2 years</li></ul>
Learn more:
Neal Ready: <a href= "mailto: neal.ready@duke.edu">neal.ready@duke.edu</a> or 919-684-7218
Monika Anand: <a href= "mailto: monika.anand@duke.edu">monika.anand@duke.edu</a> or 919-681-8838
Ann Marie Peters: <a href= "mailto: annemarie.peters@duke.edu">annemarie.peters@duke.edu</a> or 919-681-4768
<li>Have a diagnosis of stage1B-3A NSCLC</li>
<li>Meet specific diagnostic criteria relating to your disease</li>
<li>Are a candidate for surgery to treat your disease</li>
<li>Agree to have your blood drawn for research</li>
<li>Have not had any chemotherapy, radiation therapy, or biologic/targeted therapy for your current diagnosis</li>
<li>Have not had any other invasive cancers in the past 2 years</li></ul>
Learn more:
Neal Ready: <a href= "mailto: neal.ready@duke.edu">neal.ready@duke.edu</a> or 919-684-7218
Monika Anand: <a href= "mailto: monika.anand@duke.edu">monika.anand@duke.edu</a> or 919-681-8838
Ann Marie Peters: <a href= "mailto: annemarie.peters@duke.edu">annemarie.peters@duke.edu</a> or 919-681-4768
What is Involved?
If you choose to join the study, you will:<ul>
<li>Have a screening visit to make sure it is safe for you to participate</li>
<li>Have tumor imaging tests (MRIs, CTs, and/or PET/CTs)</li>
<li>Have physical exams</li>
<li>Have reviews of your medications, symptoms, and medical history</li>
<li>Have blood draws</li>
<li>Have pregnancy tests (if you are a person who is able to get pregnant) </li></ul>
For your study regimen, you will get a random assignment (like a coin flip) to one of two treatment groups:<ul>
<li>Chemotherapy and cemiplimab with alirocumab prior to surgery; OR</li>
<li>Chemotherapy and cemiplimab without alirocumab prior to surgery</li></ul>
<li>Have a screening visit to make sure it is safe for you to participate</li>
<li>Have tumor imaging tests (MRIs, CTs, and/or PET/CTs)</li>
<li>Have physical exams</li>
<li>Have reviews of your medications, symptoms, and medical history</li>
<li>Have blood draws</li>
<li>Have pregnancy tests (if you are a person who is able to get pregnant) </li></ul>
For your study regimen, you will get a random assignment (like a coin flip) to one of two treatment groups:<ul>
<li>Chemotherapy and cemiplimab with alirocumab prior to surgery; OR</li>
<li>Chemotherapy and cemiplimab without alirocumab prior to surgery</li></ul>
Study Details
Full Title
Safety, Efficacy, and Tumor Immune Microenvironment Changes with Neoadjuvant Chemotherapy and Cemiplimab with or without Alirocumab in Stage 1B-3A Non-Small Cell Lung Cancer: TOP 2301 (PO# 1157693 R2810-ONC-2347)
Principal Investigator
Neal
Ready
Protocol Number
PRO00114645
NCT ID
NCT06385262
Phase
II
Enrollment Status
Pending Open to Enrollment