eligibility_summary
Eligibility: Adults with advanced/metastatic NSCLC, EGFR Ex19del or L858R confirmed by approved/validated test, ≥1 measurable, non-irradiated lesion (RECIST v1.1), prior AEs resolved to ≤Grade1 (exceptions: alopecia, ≤Grade2 neuropathy/hypothyroid on replacement), ECOG 0–1. Exclude active ILD/radiation pneumonitis, major recent/unrecovered/planned surgery or significant trauma, uncontrolled tumor pain, recent/ongoing investigational therapy, interfering second malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06667076 (Phase 2b) in EGFR-mutated (Ex19del/L858R) advanced/metastatic NSCLC. Interventions: (1) Subcutaneous amivantamab + oral lazertinib (first-line). (2) Subcutaneous amivantamab + carboplatin + pemetrexed (second-line). Mechanisms: Amivantamab—bispecific IgG1 monoclonal antibody against EGFR and MET, blocks ligand/receptor signaling, promotes receptor internalization/degradation, and induces Fc-mediated ADCC/ADCP. Lazertinib—third-generation, irreversible, CNS-penetrant EGFR TKI targeting activating mutations (and T790M) with reduced wild-type EGFR inhibition. Carboplatin—platinum DNA crosslinker causing replication stress/apoptosis. Pemetrexed—antifolate inhibiting TS, DHFR, GARFT to block DNA/RNA synthesis. Targets/pathways: EGFR- and MET-driven tumor cells, downstream MAPK and PI3K–AKT signaling, chemotherapy targets rapidly dividing tumor cells, engages NK/macrophage effector cells via amivantamab.