Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week In… (NCT07298148) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg
28 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From dose escalation (Week 8) until documented disease progression or start of new anticancer therapy, assessed approximately every 8 weeks, up to 24 months.
Trial details
NCT IDNCT07298148
SponsorPeking University Cancer Hospital & Institute