Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborator: Allist Pharmaceuticals, Inc.
• Treatments: Aflutinib

Criteria

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.