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.
Estadio1B-3A cáncer de pulmón de células no pequeñas (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?
Si decide participar en el estudio, podrá:
- Realice una visita de detección para asegurarse de que sea seguro para usted participar.
- Realizar estudios de imágenes tumorales (RM, TC y/o PET/TC)
- Someterse a exámenes físicos
- Realice revisiones de sus medicamentos, síntomas y historia clínica.
- Realizar extracciones de sangre
- Realice pruebas de embarazo (si es una persona que puede quedar embarazada))
Para su régimen de estudio, recibirá una asignación al azar (como lanzar una moneda) a uno de los dos grupos de tratamiento:
- quimioterapia y cemiplimab con alirocumab antes de la cirugía; O
- Quimioterapia y cemiplimab sin alirocumab antes de la cirugía.
Study Details
