Clinical trial · Interventional
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
Furmonertinib Mesylate as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable, EGFR Sensitizing Mutation Positive Lung Adenocarcinoma Patients: A Phase II, Single-arm, Open-label Clinical Study (FRONT)
NCT04965831CI-TRIAL-00052738unknownPhase 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 is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Furmonertinib | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Furmonertinib
- description
- Furmonertinib as perioperation therapy
- interventionNames
- Drug: Furmonertinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Approximately 8 weeks following the first dose of study drug
- description
- Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
Secondary outcomes (4)
- measure
- Disease Control Rate (DCR)
- timeFrame
- Approximately 8 weeks following the first dose of study drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study. * Primary lung adenocarcinoma diagnosed histologically/cytologically. * Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators. * EGFR mutation positive (19Del or L858R, with or without T790M) * The presence of at least one measurable lesion and suitable for accurate repeated measurements. * ECOG performance status 0-1. * For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose. Exclusion Criteria: * Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma. * Patients with EGFR exon 20 insertion mutation. * Exposure to other antitumor therapies prior to enrolment. * Major surgery was performed in the four weeks prior to the first dosing of the study drug. * Pregnant or lactating female patients. * Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration. * Have a history of or present complications with other malignancies. * Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study. * ECG QT interval prolongation or associated risk. * A history of interstitial pneumonia or related risk. * Inadequate bone marrow or organ reserve. * Other circumstances that are not suitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.