eligibility_summary
Adults ≥18 with EGFR Ex19del/L858R locally advanced/metastatic NSCLC, treatment‑naïve for metastatic disease, prior adjuvant/neoadjuvant/locally advanced therapy allowed (>12 mo before recurrence). Need EGFR report, tumor tissue+blood, adequate organs, ECOG 0–2, measurable lesion. Stable brain mets allowed. Exclude prior EGFR TKI/metastatic systemic therapy, active CNS disease, ILD/pneumonitis, uncontrolled illness, active HBV/HCV/TB, active CV disease, strong CYP3A4/5 I/Is, recent major surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm first-line study in EGFR-mutant (Ex19del/L858R) metastatic NSCLC testing: 1) Amivantamab—low-fucose, fully human IgG1 bispecific monoclonal antibody (biologic) targeting EGFR and MET, inhibits EGFR/MET signaling and shows activity against EGFR activating/resistance mutations (e.g., T790M/C797S) and MET pathway activation. 2) Lazertinib—mutant-selective small-molecule EGFR tyrosine kinase inhibitor active vs Ex19del/L858R and T790M, with reduced activity on wild-type EGFR. 3) Pemetrexed—antifolate antimetabolite chemotherapy that inhibits folate-dependent enzymes to block DNA synthesis. Targets: EGFR signaling, MET bypass pathway, and folate metabolism in proliferating tumor cells.