Clinical trial · Interventional
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
NCT07298148CI-TRIAL-00101226not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
| EGFR-TKI Sensitizing Mutation | — | UNRESOLVED | — |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Firmonertinib 160mg | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Firmonertinib 160mg
- interventionNames
- Drug: Firmonertinib 160mg
Primary outcomes (1)
- measure
- 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.
- description
- Percentage of patients achieving CR or PR per RECIST v1.1.
Secondary outcomes (5)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From first dose to disease progression or death, whichever occurs first; followed for up to 24 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.