EGFR Positive Non-small Cell Lung Cancer, EGFR-TKI Sensitizing Mutation, NSCLC Stage IV
Conditions
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.
Interventions
DRUGFirmonertinib 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.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (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. | Percentage of patients achieving CR or PR per RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
| 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. | Percentage of patients achieving CR, PR, or SD.per RECIST v1.1. |
| 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. | Duration from first response to progression or death. |
| 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. | Evaluated via CNS imaging per RECIST v1.1 or applicable CNS criteria. |
| 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. | any adverse event that in the investigator's opinion may have been caused by the study medication with reasonable possibility per CTCAE 5.0. |
Contacts
CONTACTSen Han, MD
Outcome results
None listed