Menu
Not yet recruiting NCT07298148

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

Phase II Interventional NSCLC Stage IV EGFR Positive Non-small Cell Lung Cancer EGFR-TKI Sensitizing Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Firmonertinib 160mg.
Who it may be relevant to
Registry conditions: NSCLC Stage IV, EGFR Positive Non-small Cell Lung Cancer, EGFR-TKI Sensitizing Mutation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: 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 (5)
  • Progression-Free Survival (PFS) [Time frame: From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.]
  • Disease Control Rate (DCR) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: From first dose of therapy through 30 days after last dose of study treatment up to 24 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07298148 · 2025YJZ88

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗