eligibility_summary
Inclusion: advanced/metastatic EGFR‑mutated (Ex19del/L858R) NSCLC, ECOG 0–1, progressed after osimertinib and platinum chemo, prior 1st/2nd‑gen EGFR TKI allowed, consent, contraception required (women on OCP add barrier, men use condoms during and 3 mo post). Exclusion: ILD/radiation pneumonitis, PD‑1/PD‑L1 within 6 wks or unresolved immune rash, symptomatic brain mets (treated, off steroids, stable ≥2 wks allowed), unresolved >G1 toxicities (exceptions noted), prior amivantamab/lazertinib.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-group trial in EGFR-mutated NSCLC post-osimertinib tests premedication to reduce amivantamab infusion-related reactions: oral dexamethasone (glucocorticoid anti-inflammatory), oral montelukast (CysLT1 leukotriene-receptor antagonist), and subcutaneous low-dose methotrexate (antifolate immunomodulator). Background therapy is amivantamab + lazertinib. Amivantamab is a bispecific IgG1 monoclonal antibody against EGFR and MET that blocks signaling, promotes receptor downregulation, and triggers Fc-mediated ADCC, lazertinib is a third-generation, mutant-selective, irreversible EGFR TKI. Targets/pathways: EGFR/MET-driven tumor signaling (MAPK/PI3K) and Fc-engaged NK cells, IRR pathways in mast cells/basophils/eosinophils and mediator cascades (histamine/leukotrienes, IL-1/IL-6/TNF) suppressed by the premeds.