TOP 2301: Neoadjuvant Chemo for NSCLC (NCT06385262) | Clinical Trial Compass
SuspendedPhase 2
TOP 2301: Neoadjuvant Chemo for NSCLC
Stopped: Protocol is currently undergoing study design revisions and will re-open after amendment is IRB approved
United States126 participantsStarted 2025-03-17
Plain-language summary
In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery.
Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1).
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. 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.
✓. Clinical stage IB, IIA/IIB, or III (N0-2) amenable to surgical resection.
✓. Primary tumor size of ≥ 3 cm (for all clinical stages to insure adequate tumor for correlative studies).
✓. Agrees to research blood collections for study.
✓. Deemed a surgical candidate.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. No prior chemotherapy, radiation therapy or biologic/targeted therapy for current diagnosis of lung cancer.
Exclusion criteria
✕. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment.
What they're measuring
1
Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab.