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

Tianjin Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

Lung Adenocarcinoma

Treatments

Drug: Furmonertinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04965831

AST-PMR2003

Details and patient eligibility

About

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.

Full description

Please refer to detailed description in the following context.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.