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

NCT07298148 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025YJZ88
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

NSCLC Stage IV; EGFR Positive Non-small Cell Lung Cancer; EGFR-TKI Sensitizing Mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-Free Survival (PFS)

  From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.

• Disease Control Rate (DCR)

  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)

  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)

  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)

  From first dose of therapy through 30 days after last dose of study treatment up to 24 months.

Study Arms (1)

Firmonertinib 160mg

EXPERIMENTAL

Drug: Firmonertinib 160mg

Interventions

Firmonertinib 160mg DRUG

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.

Firmonertinib 160mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sen Han, MD

CONTACT

010-88121122; handsomehansen1@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share