NCT07298148Not yet recruitingPhase 2
Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg
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
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Lung cancer
- NCT number
- NCT07298148
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 28
- From 1 Jan 2026 to the primary completion date, 31 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CR, PR, or PD at completion of induction therapy.
Other illness
- Hypersensitivity to Firmonertinib or related compounds.
- Unresolved toxicities \>CTCAE Grade 1 (except allowed conditions).
- GI disorders impairing drug absorption.
- Uncontrolled systemic diseases or active infections (HBV/HCV/HIV).
- Interstitial lung disease (history or active).
- Any condition compromising compliance.
Lab values
- Prior EGFR-TKI therapy or prohibited concomitant medications.
- Clinically significant cardiac abnormalities including QTc \>470 ms or LVEF \<50%.
Other
- Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53/RB1).
- Symptomatic CNS metastases or spinal cord compression.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.