This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.
Age 18-75 years.
ECOG performance status 0-1; life expectancy ≥3 months.
Histologically/cytologically confirmed advanced/metastatic non-squamous NSCLC unsuitable for curative therapy.
Documented EGFR 19del or L858R mutation.
Hypersensitivity to Firmonertinib or related compounds.
Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53/RB1).
Prior EGFR-TKI therapy or prohibited concomitant medications.
Unresolved toxicities >CTCAE Grade 1 (except allowed conditions).
Peking University Cancer Hospital & Institute
Lead sponsor