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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Furmonertinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05445310

AST-PMR2201

Details and patient eligibility

About

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.

Enrollment

114 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.