eligibility_summary
Key inclusion: resectable stage II–IIIB (N2) NSCLC, measurable disease (RECIST 1.1), FFPE tumor available, ECOG 0–1, adequate organ/bone marrow function. Key exclusion: prior systemic therapy/radiation for current tumor, EGFR/ALK alterations, ≥grade 2 neuropathy, other active/progressing cancer. Arm 1 exclusions: ≥grade 3 hypercalcemia, CNS pathology increasing ICANS risk, prolonged QT/QTc or risk factors. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized phase 2 perioperative trial in resectable stage II–IIIB NSCLC. Arms: 1) Control: cemiplimab (anti-PD-1 monoclonal antibody checkpoint inhibitor) + platinum-based chemotherapy (platinum compounds, DNA cross-linking cytotoxics). 2) Experimental: same regimen plus REGN7075 (EGFRxCD28 bispecific T-cell costimulatory antibody). Mechanisms/targets: Cemiplimab blocks PD-1 on T cells to restore antitumor activity (PD-1/PD-L1 checkpoint). Platinum chemotherapy damages tumor DNA, inducing apoptosis and immunogenic cell death. REGN7075 engages EGFR on tumor cells and CD28 on T cells to provide conditional costimulation, amplifying T-cell activation in concert with PD-1 blockade. Tumors with activating EGFR or ALK alterations are excluded.