eligibility_summary
Tx-naive advanced/metastatic NSCLC with EGFR Ex19del or L858R (validated test). Prior adjuvant/neoadjuvant allowed if >12 mo. Brain mets allowed if treated/stable (≥14 d, ≤10 mg prednisone/day). Second malignancy allowed, no skin cancers in amivantamab SC cohort. Sub-study: persistent/new Grade ≥2 EGFRi skin AEs. Exclude uncontrolled illness/infection, ILD, allergies to study drugs, prior systemic Tx for IIIB/C-IV, leptomeningeal disease, sub-study: prior JAK (A) or calcineurin (B).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, randomized study in first-line EGFR-mutated NSCLC testing enhanced vs standard dermatologic care during amivantamab + lazertinib to reduce ≥Grade 2 rash/paronychia. Anticancer backbone: amivantamab (IV or SC), a bispecific IgG1 monoclonal antibody targeting EGFR and MET (blocks signaling, induces receptor downregulation and ADCC on tumor cells), lazertinib, an oral third‑generation irreversible EGFR TKI (active vs Del19/L858R and T790M). Dermatologic strategies: doxycycline/minocycline (oral tetracyclines, anti-inflammatory/antibacterial), clindamycin lotion (lincosamide), chlorhexidine (antiseptic), noncomedogenic moisturizer (barrier). Substudy/expansion early interventions: topical ruxolitinib (JAK1/2 inhibitor), topical tacrolimus (calcineurin/NFAT inhibitor), clobetasol (topical corticosteroid), propranolol oral and timolol topical (nonselective beta-blockers), zinc gluconate. Targets/pathways: tumor EGFR/MET, cutaneous JAK-STAT in keratinocytes/immune cells, T-cell activation, beta-adrenergic/angiogenic tone, microbial load, neutrophilic inflammation, and skin barrier.