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NCT Number: NCT07298148

Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD 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.

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Key information

Conditions

NSCLC Stage IV Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Positive Non-small Cell Lung Cancer EGFR-TKI Sensitizing Mutation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Percentage of patients achieving CR or PR per RECIST v1.1.

Secondary outcomes

  1. Progression-Free Survival (PFS)

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

    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.

  2. 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.

    Percentage of patients achieving CR, PR, or SD.per RECIST v1.1.

  3. 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.

    Duration from first response to progression or death.

  4. 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.

    Evaluated via CNS imaging per RECIST v1.1 or applicable CNS criteria.

  5. 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.

    any adverse event that in the investigator's opinion may have been caused by the study medication with reasonable possibility per CTCAE 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Sen Han, MD

CONTACT

[email protected]

010-88121122

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Dec 23, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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