Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg

Peking University Cancer Hospital & Institute

Status and phase

Not yet enrolling

Phase 2

Conditions

EGFR Positive Non-small Cell Lung Cancer

NSCLC Stage IV

EGFR-TKI Sensitizing Mutation

Treatments

Drug: Firmonertinib 160mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07298148

2025YJZ88

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
No prior systemic therapy for advanced disease.
Stable disease after 8 weeks of Firmonertinib 80 mg daily.
more than 1 measurable lesion per RECIST v1.1.
Adequate hematologic, renal, hepatic, and coagulation function.
Signed written informed consent.

Exclusion criteria

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).
Symptomatic CNS metastases or spinal cord compression.
GI disorders impairing drug absorption.
Uncontrolled systemic diseases or active infections (HBV/HCV/HIV).
Interstitial lung disease (history or active).
Clinically significant cardiac abnormalities including QTc >470 ms or LVEF <50%.
Pregnancy or breastfeeding.
Any condition compromising compliance.
CR, PR, or PD at completion of induction therapy.