Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.

Official Title
-----------------
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study

Conditions
-----------------
Non-small Cell Lung Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy. Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists. Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging. EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al. ECOG performance status 0-1. Sufficient organ function in liver, renal, kidney and hematology. With written signed informed consent form, ability to report adverse events, and good adherence to clinical study. Exclusion Criteria: Lung cancer with small cell or neuroendocrine cancer cell. EGFR exon 20 insertion positive. Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al. Women who are pregnant or breastfeeding. Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment. Concurrent with other malignancies excluding carcinoma in situ. With uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections requiring injection of antibiotics. Gastrointestinal disorders which may affect drug taking or absorption. With history of QT prolongation or relative risk factors including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al. With history of interstitial lung disease or relative risk. Allergic to any component of furmonertinib tablet. Mental illness or drug abuse. Live vaccination within 30 days before enrollment. Other situation judged by investigator such as failure to follow the rules of study. Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.

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>Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons. | Drug: Furmonertinib<br>* Furmonertinib 80mg/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival rate at 3 years | The rate of survival patients without disease recurrence at 3 years | 3 years following the first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate at 3 years | The rate of survival patients at 3 years | 3 years following the first dose of study drug | 
| Median disease-free survival | The median time from the enrollment to the disease recurrence or death depending on the protocol | Approximately 3 years following the first dose of study drugs | 
| Median overall survival | The median time from the enrollment to death of any cause depending on the protocol | Approximately 5 years following the first dose of study drugs | 
| Adverse events | The number of patients with adverse events and the severity according to CTCAE v5.0 | Approximately 3 years following the first dose of study drugs |