eligibility_summary
Incl: histologic non‑squamous (incl mixed) NSCLC that is advanced/metastatic or recurrent, not curable, WHO PS 0–1, LE>12 wks, common sensitizing EGFR mutation, ≥1 measurable lesion ≥10 mm. Excl: serious illness, malabsorption, unresolved tox >G1 (except alopecia/G2 neuropathy), unstable/symptomatic brain mets, active TB/HBV/HCV, HIV per protocol, cardiac disease, ILD, TdP‑risk meds, prior/concurrent systemic tx or EGFR‑TKI, recent RT/major surgery, strong CYP3A4 inducers, drug hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05801029 (OSTARA) evaluates first-line osimertinib plus amivantamab in EGFR-mutated (Ex19del/L858R) locally advanced/metastatic non-squamous NSCLC. Osimertinib: small-molecule, third-generation, irreversible EGFR tyrosine kinase inhibitor, selective for mutant EGFR (including T790M), shutting down EGFR signaling and downstream MAPK/ERK and PI3K/AKT pathways. Amivantamab: bispecific IgG1 monoclonal antibody targeting EGFR and MET, blocks ligand binding, induces receptor internalization/degradation, and triggers Fc-mediated ADCC/ADCP. Targets: EGFR-mutant tumor cells and MET-driven resistance pathways, inhibition of EGFR/MET signaling with engagement of immune effector cells (e.g., NK/macrophages) to eliminate EGFR/MET-expressing NSCLC cells.