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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Please refer to detailed description in the following context.

Official Title
-----------------
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)

Conditions
-----------------
Lung Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Furmonertinib


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furmonertinib<br>Furmonertinib as perioperation therapy | Drug: Furmonertinib<br>* Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.<br>* Other names: AST2818;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1 | Approximately 8 weeks following the first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1 | Approximately 8 weeks following the first dose of study drug | 
| Progression free survival (PFS) | The time from the first does of the study drugs to the progression of the disease or death for any reason. | Approximately 3 years following the first dose of study drug | 
| Disease free survival (DFS) | The time from the end of surgery to the progression of the disease or death for any reason. | Approximately 3 years following the first dose of study drug | 
| Adverse Events (AEs) | The number of patients with adverse events and the severity according to CTCAE v5.0 | From the start of study drug to 28 days after the last dose of study drug |