TOP 2301: Neoadjuvant Chemo for NSCLC - Clinical Trial
What is the 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.
Stage1B-3A Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Have a diagnosis of stage1B-3A NSCLC
- Meet specific diagnostic criteria relating to your disease
- Are a candidate for surgery to treat your disease
- Agree to have your blood drawn for research
- Have not had any chemotherapy, radiation therapy, or biologic/targeted therapy for your current diagnosis
- Have not had any other invasive cancers in the past 2 years
Learn more:
Neal Ready: neal.ready@duke.edu or 919-684-7218
Monika Anand: monika.anand@duke.edu or 919-681-8838
Ann Marie Peters: annemarie.peters@duke.edu or 919-681-4768
What is Involved?
If you choose to join the study, you will:
- Have a screening visit to make sure it is safe for you to participate
- Have tumor imaging tests (MRIs, CTs, and/or PET/CTs)
- Have physical exams
- Have reviews of your medications, symptoms, and medical history
- Have blood draws
- Have pregnancy tests (if you are a person who is able to get pregnant)
For your study regimen, you will get a random assignment (like a coin flip) to one of two treatment groups:
- Chemotherapy and cemiplimab with alirocumab prior to surgery; OR
- Chemotherapy and cemiplimab without alirocumab prior to surgery
Study Details
