eligibility_summary
Adults with confirmed unresectable non‑squamous NSCLC, stage IIIB–IV, no prior systemic therapy for advanced disease (adjuvant/neoadjuvant allowed if >6 mo), ≥1 measurable non‑brain lesion (RECIST 1.1), ECOG 0–1, life expectancy ≥3 mo, adequate organ function. Exclude actionable drivers with approved drugs, recent RT/surgery/TCM, pericardial effusion, leptomeningeal disease/spinal cord compression, unstable brain mets (treated stable ≥2 wks off steroids or asymptomatic allowed).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, first‑line EGFR‑mutant non‑squamous NSCLC. Interventions: • JMT101 + osimertinib vs osimertinib alone. Drug types and mechanisms: • JMT101: recombinant humanized anti‑EGFR monoclonal antibody (biologic, IV). Binds EGFR’s extracellular domain to block ligand binding/dimerization, suppress downstream signaling, and may engage Fc‑mediated ADCC. • Osimertinib: third‑generation, irreversible small‑molecule EGFR tyrosine kinase inhibitor (oral). Selectively inhibits mutant EGFR (e.g., exon 19 del, L858R, also active vs T790M) by covalently binding the ATP site. Target cells/pathways: • EGFR‑mutant NSCLC tumor cells. • EGFR/ErbB signaling cascades, chiefly RAS‑RAF‑MEK‑ERK and PI3K‑AKT pathways. • Potential immune effector cells (e.g., NK cells) via antibody‑mediated cytotoxicity. Aim: deeper EGFR pathway blockade and delayed resistance.