Duke University
This study was originally opened on 10/22/2024 as an open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) to receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery. As of 7/20/2026, the study was amended to a single arm receiving neoadjuvant chemotherapy, cemiplimab every 3 weeks for 3 cycles and alirocumab every 4 weeks prior to surgery. The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor.
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histological/cytological diagnosis of non-small cell lung cancer (NSCLC). Patient is eligible to enroll in the study based on clinical suspicion of NSCLC but are required to have a histological diagnosis of NSCLC in order to be eligible to receive treatment on study. 3. Clinical stage IB, IIA/IIB, or III (N0-2) amenable to surgical resection. 4. Agrees to research blood collections for study. 5. Deemed a surgical candidate. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. No prior chemotherapy, radiation therapy or biologi…
300 mg subcutaneously every 4 weeks prior to surgery
350mg IV every 3 weeks prior to surgery
Treating provider's choice of FDA approved platinum doublet chemotherapy IV every 3 weeks prior to surgery
Arctuva estimate
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