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

A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC Stage IV; EGFR-TKI Sensitizing Mutation; EGFR Positive Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Firmonertinib 160mg

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sen Han, MD; Phone Number: 010-88121122; Email: handsomehansen1@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Firmonertinib 160mg	Drug: Firmonertinib 160mg; Patients enter an 8-week induction phase at 80 mg once daily. Those with stable disease per RECIST v1.1 at Week 8 escalate to 160 mg daily until disease progression or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Percentage of patients achieving CR or PR per RECIST v1.1.	From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Time from the start of randomization (or the start of treatment in a single-arm trial) to tumor progression or death from any cause, whichever occurs first.	From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.
Disease Control Rate (DCR)	Percentage of patients achieving CR, PR, or SD.per RECIST v1.1.	From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
Duration of Response (DoR)	Duration from first response to progression or death.	From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
CNS Objective Response Rate (CNS-ORR)	Evaluated via CNS imaging per RECIST v1.1 or applicable CNS criteria.	From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
Incidence of Treatment-related adverse event (TRAE)	any adverse event that in the investigator's opinion may have been caused by the study medication with reasonable possibility per CTCAE 5.0.	From first dose of therapy through 30 days after last dose of study treatment up to 24 months.

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2025YJZ88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No