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

Starting soon · Phase 2

Conditions studied: NSCLC Stage IV, EGFR Positive Non-small Cell Lung Cancer, EGFR-TKI Sensitizing Mutation

In brief

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.

Key facts

Study ID

NCT07298148

Run by

Peking University Cancer Hospital & Institute

People needed

28

Starts

2026-01-01

Expected to finish

2032-12-31

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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