eligibility_summary
Adults ≥18 with resectable NSCLC (UICC8 IB–II–selected IIIA), oncogenic EGFR mutation, ECOG 0–1, measurable disease, no distant/extensive mediastinal mets, adequate lungs (ppFEV1/DLCO >30%), organs, and LVEF ≥50. Exclude: no EGFR/wrong stage, ILD, major CV disease or O2 need, immunosuppression/transplant, active HIV/HBV/HCV or other recent cancers, uncontrolled illness, pregnancy/breastfeeding, recent major surgery/live vaccine, prior amivantamab/EGFR TKI, severe infusion reactions, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NEOpredict-EGFR (Phase 2) tests 4 weeks of neoadjuvant therapy in resectable EGFR-mutant NSCLC. Interventions: 1) Amivantamab (IV), a fully human bispecific IgG1 monoclonal antibody (immunotherapy) targeting EGFR and MET. Mechanism: binds extracellular domains to block ligand binding and signaling, induces receptor internalization/degradation, and triggers Fc-mediated ADCC/ADCP by immune effectors. 2) Amivantamab plus chemotherapy: carboplatin (platinum DNA cross-linking cytotoxic) and pemetrexed (antifolate antimetabolite inhibiting TS, DHFR, GARFT) on day 1. Targets/pathways: EGFR- and MET-driven tumor cells (e.g., exon 19 del, L858R, exon 20 ins), suppressing RTK→RAS/MAPK and PI3K/AKT signaling, chemotherapy targets rapidly dividing tumor cells via DNA damage and inhibition of nucleotide synthesis before curative surgery.