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

Phase 2Not Yet RecruitingNCT07298148

Peking University Cancer Hospital & Institute28 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Firmonertinib 160mgDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

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

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 Outcomes

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.

Time frame: 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.

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)

Duration from first response to progression or death.

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)

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

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)

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

Central Contacts

Sen Han, MD

CONTACT

010-88121122 handsomehansen1@126.com

Data from ClinicalTrials.gov

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